Professional Documents
Culture Documents
BC Ministry of Health
First published March 2007
Reviewed & revised December 2011
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Foreword
This document was originally developed in 2006 by the Ontario Provincial Infectious Diseases Advisory
Committee (PIDAC) and was approved by the Ontario Ministry of Health and Long-Term Care
(MOHLTC). PIDAC is a multidisciplinary scientific advisory body that provides evidence-based advice to
the Chief Medical Officer of Health regarding multiple aspects of infectious disease identification,
prevention and control. PIDACs work is guided by the best available evidence and updated as required.
Best practice documents and tools produced by PIDAC reflect consensus positions on what the
committee deems prudent practice and are made available as a resource to public health and health care
providers.
In 2006, the British Columbia (BC) Ministry of Health (the Ministry) received permission to adopt PIDACs
Best Practices for Cleaning, Disinfection and Sterilization of Medical Devices. Permission was also
granted at that time for the Ministry to amend contextual material within the document to better fit BCs
health services environment. An adapted version of the PIDAC guidelines was issued as BC's provincial
policy in 2007. The policy applies to all critical and semi-critical single use and multiple use devices and
patient care equipment used within health authority facilities and programs, as well as private and nonprofit facilities providing public healthcare services under contract to health authorities.
In February 2010, PIDAC published a revised version of the guidelines and the MOHLTC once again
gave permission to the BC Ministry of Health to use its updated best practices document to further
improve patient safety in BC. The Ministry extends its thanks and appreciation to its colleagues in
Ontario for supporting inter-provincial learning in the area of medical device reprocessing.
This document incorporates revisions from the following updated Canadian standards:
CSA Z314.3-09 Effective Sterilization in Health Care Facilities by the Steam Process
CSA Z314.2-09 Effective Sterilization in Health Care Facilities by the Ethylene Oxide Process
CSA Z314.8-08 Decontamination of Reusable Medical Devices
The Provincial Infection Control Networks (PICNet) recommendation for a provincial minimum
standard for the reprocessing of flexible endoscopes has been adopted in this revision.
New information from the Centers for Disease Control and Preventions Guideline for Disinfection
and Sterilization in Healthcare Facilities, published in 2008, is also reflected in this revision.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
This updated provincial reprocessing policy also reflects recommendations made by Dr. Douglas
Cochrane, Chair of the BC Patient Safety & Quality Council, to the Ministry and health authorities in
September 2010.
Acknowledgement
Ontario Ministry of Health and Long-Term Care & the Provincial Infectious Diseases Advisory Committee.
Best Practices for Cleaning, Disinfection and Sterilization in All Health Care Settings. February 2010.
Available at:
http://www.health.gov.on.ca/english/providers/program/infectious/diseases/best_prac/bp_cds_2.pdf
Content from Ontario / PIDAC best practice document is Ontario Ministry of Health and Long-Term
Care/Public Health Division / Provincial Infectious Diseases Advisory Committee
Toronto, Canada
February 2010
ISBN: 978-1-4435-1526-9
In February 2010, the BC Ministry of Health was granted permission by PIDAC to adopt and adapt their
document entitled Best Practices for Cleaning, Disinfection and Sterilization in All Health Care Settings.
All updated content is BC Ministry of Health / BC Health Authorities / Providence Health Care.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
The BC Ministry of Health would like to acknowledge the contribution and expertise of PIDACs
subcommittee that developed the original best practice document:
Infection Prevention and Control Subcommittee:
Dr. Mary Vearncombe, Chair
Medical Director
Infection Prevention and Control, Microbiology
Sunnybrook Health Sciences Centre and Womens
College Hospital
Toronto, Ontario
Dr. Irene Armstrong
Associate Medical Officer of Health
Toronto Public Health
Toronto, Ontario
Donna Baker
Manager, Infection Prevention and Control
Bruyre Continuing Care
Ottawa, Ontario
Mary Lou Card
Manager, Infection Prevention and Control
London Health Sciences Centre and St. Josephs
Health Care
London, Ontario
Dr. Maureen Cividino
Occupational Health Physician
St. Joseph's Healthcare
Hamilton, Ontario
Dr. Kevin Katz
Infectious Diseases Specialist and Medical
Microbiologist
Medical Director, Infection Prevention and Control
North York General Hospital
Toronto, Ontario
Dr. Allison McGeer
Director, Infection Control
Mount Sinai Hospital
Toronto, Ontario
Pat Piaskowski
Network Coordinator
Northwestern Ontario Infection Control Network
Thunder Bay, Ontario
Dr. Virginia Roth
Director, Infection Prevention and Control
The Ottawa Hospital
Ottawa, Ontario
Dr. Kathryn Suh
Associate Director, Infection Prevention and Control
The Ottawa Hospital
Ottawa, Ontario
Liz Van Horne
Senior Infection Prevention and Control Professional
Infectious Disease Prevention and Control
Agency for Health Protection and Promotion
Toronto, Ontario
Dr. Dick Zoutman
Professor and Chair
Divisions of Medical Microbiology and Infectious
Diseases
Medical Director of Infection Control
South Eastern Ontario Health Sciences Centre
Queens University
Kingston, Ontario
Co-Chair, Provincial Infectious Diseases Advisory
Committee (PIDAC)
Dr. Beth Henning (ex-officio)
Senior Medical Consultant
Ministry of Health and Long-Term Care
Director, Infection Control
Mount Sinai Hospital
Toronto, Ontario
PIDAC would also like to acknowledge the writing of this best practices guide provided by Shirley McDonald.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
The BC Ministry of Health would like to acknowledge the contribution and expertise of the following people in the
development and adaptation of this best practice document for use in British Columbia:
BC Provincial Reprocessing Working Group:
Penny Brawn
Regional Coordinator, Sterile Processing, Northern
Health Authority
Sheila Konishi
Program Director, Sterile Processing Fraser Health
Authority
Janet Bristeir
Regional Medical Device Reprocessing Practice &
Quality Coordinator, Vancouver Coastal Health
Authority
Darren Kopetsky
Director, Medical Affairs (Risk Management),
Vancouver Coastal Health Authority
Viola Tang
Infection Control & Reprocessing Practices Manager,
Provincial Health Services Authority
Laurie Buist
Reprocessing Practice Leader, Interior Health
Authority
Fern Christensen
Coordinator, Medical Device Reprocessing,
Vancouver Island Health Authority
Dianne Trudeau
Operations Leader, Sterile Processing, Mount. St.
Josephs & St. Pauls Hospital, Providence Health
Care
Ruby Fraser
Coordinator, Quality, Risk Management & Education,
Northern Health Authority
Petra Welsh
Administrative Director, Infection Control, Fraser
Health Authority
Laurie Buist
Reprocessing Practice Leader, Interior Health
Authority
Barbara Bolding
Medical Device Reprocessing Consultant
Sheila Konishi
Program Director, Sterile Processing, Fraser Health
Authority
Penny Brawn
Regional Coordinator, Sterile Processing, Northern
Health Authority
Viola Tang
Infection Control & Reprocessing Practices Manager,
Provincial Health Services Authority
Other Contributors:
Dr. Michelle Alfa
Medical Director, Clinical Microbiology Discipline, Diagnostic Services of Manitoba
Dr. Elizabeth Bryce
Co-Director, Provincial Infection Control Network
Regional Medical Director, Infection Control, Vancouver Coastal Health Authority
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Albert Csapo
Manager, Sterile Processing, Vancouver Coastal Health Authority
Sandra Daniels
Coordinator, Infection Prevention and Control, Fraser Health Authority
Bruce Gamage
Network Manager, Provincial Infection Control Network
Dr. Judith Isaac-Renton
Co-Director, Provincial Infection Control Network
Public Health Laboratory Director, BC Centre for Disease Control
College of Physicians & Surgeons of BC
Provincial Infection Control Networks Community of Practice
All other provincial contributors from the fields of infection control, medical device reprocessing, risk
management and health operations.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Table of Contents
TABLE OF CONTENTS................................................................................................................................................ 7
ABBREVIATIONS ................................................................................................................................................... 10
GLOSSARY OF TERMS ............................................................................................................................................. 10
PREAMBLE .......................................................................................................................................................... 14
ABOUT THIS DOCUMENT ........................................................................................................................................ 14
WHEN TO USE THIS DOCUMENT .............................................................................................................................. 14
ASSUMPTIONS FOR BEST PRACTICE GUIDELINES ........................................................................................................... 15
I. GENERAL PRINCIPLES ..................................................................................................................................... 20
II. BEST PRACTICES............................................................................................................................................ 22
1. ASSESSMENT AND PURCHASE OF MEDICAL DEVICES AND REPROCESSING EQUIPMENT................................................... 22
A. Device Purchases ............................................................................................................................................22
B. Manufacturers Recommendations ................................................................................................................23
C. Loaned, Shared and Leased Medical Devices ..................................................................................................24
D. Creutzfeldt-Jakob Disease (CJD) .....................................................................................................................25
2. ENVIRONMENTAL REQUIREMENTS FOR REPROCESSING AREAS ................................................................................. 26
A. Physical Space .................................................................................................................................................26
B. Air Quality .......................................................................................................................................................27
C. Water Quality .................................................................................................................................................27
D. Environmental Cleaning in Medical Device Reprocessing/Sterile Processing Departments ...........................28
3. POLICIES AND PROCEDURES ............................................................................................................................. 28
4. EDUCATION AND TRAINING ............................................................................................................................. 29
5. OCCUPATIONAL HEALTH AND SAFETY FOR REPROCESSING ...................................................................................... 30
A. Routine Practices ............................................................................................................................................31
B. Personal Protective Equipment (PPE) .............................................................................................................32
C. Safe Handling of Sharps ..................................................................................................................................32
D. Work Restrictions ............................................................................................................................................32
6. CLEANING (DECONTAMINATION) OF REUSABLE MEDICAL DEVICES ........................................................................... 33
A. Pre-Cleaning At Point of Use ...........................................................................................................................34
B Handling and Transportation of Contaminated Devices ..................................................................................34
C Preparation for Cleaning of Medical Devices ...................................................................................................35
D. Cleaning ..........................................................................................................................................................35
7. FACTORS AFFECTING PRODUCT SELECTION AND EFFICACY OF LIQUID CHEMICALS FOR DISINFECTION OR MANUAL STERILIZATION
37
A. Factors affecting efficacy.................................................................................................................................37
B. Product selection .............................................................................................................................................39
C. Terminal Reprocessing .....................................................................................................................................39
D. Reprocessing Products ....................................................................................................................................40
8. DISINFECTION OF REUSABLE MEDICAL DEVICES .................................................................................................... 40
A. Low-Level Disinfection (LLD) ...........................................................................................................................41
B. High-Level Disinfection (HLD) .........................................................................................................................41
C. Methods of Disinfection for Semi-critical Medical Devices .............................................................................41
9. REPROCESSING ENDOSCOPY DEVICES ................................................................................................................. 44
A. Education and Training ...................................................................................................................................44
B. Physical Space .................................................................................................................................................44
C. Cleaning Procedures .......................................................................................................................................45
D. Disinfection or Sterilization .............................................................................................................................46
E. Automated Endoscope Reprocessors (AER) ....................................................................................................47
F. Drying and Storage of Endoscopes and their Attachments after High Level Disinfection ...............................47
G. Accessories .....................................................................................................................................................48
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
H. Documentation ..............................................................................................................................................48
10. STERILIZATION OF REUSABLE MEDICAL DEVICES ................................................................................................... 49
A. Sterilization Process ........................................................................................................................................50
B. Steam Sterilization Methods ..........................................................................................................................50
I. DEVICE PREPARATION ....................................................................................................................... 51
II. PACKAGING ....................................................................................................................................... 52
III. LOADING ......................................................................................................................................... 52
IV. UNLOADING .................................................................................................................................... 52
V. LOAD COOL-DOWN .......................................................................................................................... 53
VI. TROUBLESHOOTINGWET PACK PROBLEMS .................................................................................. 53
VII. IMMEDIATE USE STEAM STERILIZATION (FLASH STERILIZATION).................................................... 53
VIII. TABLE TOP STERILIZERS ................................................................................................................. 54
C. Chemical (Low Temperature) Sterilization Methods ......................................................................................54
D. Sterility Assurance ..........................................................................................................................................55
E. Routine Monitoring of Sterilizers ....................................................................................................................58
F. New Sterilizers .................................................................................................................................................59
G. Unacceptable Methods of Disinfection or Sterilization ..................................................................................60
11. STORAGE AND USE OF REPROCESSED MEDICAL DEVICES ........................................................................................ 61
A. Storage Areas .................................................................................................................................................61
B. Prior to Using Sterile Devices .......................................................................................................................62
12. QUALITY ASSURANCE (QA) ............................................................................................................................. 62
A. Other Documentation ..................................................................................................................................62
B. Other Documentation ..................................................................................................................................63
C. Adverse Events .............................................................................................................................................63
D. Recalls ..........................................................................................................................................................64
13. SINGLE-USE MEDICAL DEVICES ........................................................................................................................ 65
A. Devices with Small Lumens ..........................................................................................................................65
B. Devices in Home Health Care .......................................................................................................................65
RECOMMENDATIONS SUMMARY OF BEST PRACTICES FOR CLEANING, DISINFECTION AND STERILIZATION OF MEDICAL DEVICES IN BC
HEALTH AUTHORITIES ............................................................................................................................................ 67
1. ASSESSMENT AND PURCHASE OF MEDICAL DEVICES AND REPROCESSING EQUIPMENT................................................... 67
2. ENVIRONMENTAL REQUIREMENTS FOR REPROCESSING AREAS ................................................................................. 68
3. POLICIES AND PROCEDURES ............................................................................................................................. 69
4. EDUCATION AND TRAINING ............................................................................................................................. 70
5. OCCUPATIONAL HEALTH AND SAFETY FOR REPROCESSING ...................................................................................... 71
6. CLEANING (DECONTAMINATION) OF REUSABLE MEDICAL DEVICES ........................................................................... 72
7. FACTORS AFFECTING PRODUCT SELECTION AND EFFICACY OF LIQUID CHEMICALS FOR DISINFECTION OR MANUAL STERILIZATION
74
8. DISINFECTION OF REUSABLE MEDICAL DEVICES .................................................................................................... 75
9. REPROCESSING ENDOSCOPY DEVICES ................................................................................................................. 76
10. STERILIZATION OF REUSABLE MEDICAL DEVICES ................................................................................................... 78
11. STORAGE AND USE OF REPROCESSED MEDICAL DEVICES ........................................................................................ 81
12. QUALITY ASSURANCE (QA) ............................................................................................................................. 81
13. SINGLE-USE MEDICAL DEVICES ........................................................................................................................ 82
APPENDIX A: HEALTH CANADA GUIDANCE DOCUMENT: INFORMATION TO BE PROVIDED BY MANUFACTURERS FOR THE
REPROCESSING AND STERILIZATION OF REUSABLE MEDICAL DEVICES ................................................................................ 84
APPENDIX B: REPROCESSING DECISION CHART ............................................................................................................ 87
| Page 8 of 136 pages
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
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Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Abbreviations
AER
BI
Biological Indicator
CI
Chemical Indicator
CJD
CSA
DIN
ERCP
HEPA
HLD
High-Level Disinfection
HSSBC
IPC
LLD
Low-Level Disinfection
MOHLTC
MSDS
OPA
Ortho-phthalaldehyde
PCD
PHAC
PPE
QA
Quality Assurance
QUAT
MDR/SPD
MEC
MIFU
USFDA
WHMIS
Glossary of Terms
Alcohol-Based Hand Rub (ABHR): A liquid, gel or foam formulation of alcohol (e.g., ethanol,
isopropanol) which is used to reduce the number of microorganisms on hands in clinical situations when
the hands are not visibly soiled. ABHRs contain emollients to reduce skin irritation and are less timeconsuming to use than washing with soap and water.
Assessment: A comprehensive review of reprocessing practices to identify gaps in compliance with best
practice standards.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Bioburden: The number and types of viable microorganisms that contaminate the device.
Biological Indicator (BI): A test system containing viable bacterial spores providing a defined resistance
1
to a specified sterilization process.
Chemical Indicator (CI): A system that reveals a change in one or more predefined process variables
2
based on a chemical or physical change resulting from exposure to the process.
Chemiclave: A machine that sterilizes instruments with high-pressure, high-temperature water vapour,
alcohol vapour and formaldehyde vapour (occasionally used in dental offices).
Cleaning: The physical removal of foreign material (e.g., dust, soil) and organic material (e.g., blood,
secretions, excretions, microorganisms). Cleaning physically removes rather than kills microorganisms. It
is accomplished with water, detergents and mechanical action. Cleaning must be performed before high
level disinfection or sterilization.
Client/Patient/Resident: Any person receiving health care within a health care setting.
Critical Medical Devices: Medical devices that enter sterile tissues, including the vascular system (e.g.
surgical instruments, biopsy forceps, foot care equipment, dental hand pieces, etc.). Critical medical
devices present a high risk of infection if the device is contaminated with any microorganisms, including
bacterial spores. Reprocessing critical devices involves meticulous cleaning followed by sterilization.
Decontamination: The process of cleaning, followed by the inactivation of microorganisms, in order to
3
render an object safe for handling.
Detergent: A synthetic cleansing agent that can emulsify oil and suspend soil. A detergent contains
surfactants that do not precipitate in hard water and may also contain protease enzymes (see Enzymatic
Cleaner) and whitening agents.
Disinfectant: A chemical agent that kills most disease-producing microorganisms, but not necessarily
bacterial spores. Disinfectants are applied only to inanimate objects. Some products combine a cleaner
with a disinfectant.
Disinfection: A process that kills most disease-producing microorganisms. Disinfection does not
destroy all bacterial spores. Medical devices must be cleaned thoroughly before effective disinfection can
take place. There are 3 levels of disinfection; high, intermediate and low.
Drug Identification Number (DIN): In Canada, disinfectants are regulated as drugs under the Food and
Drugs Act and Regulations. Disinfectant manufacturers shall obtain a drug identification number (DIN)
from Health Canada prior to marketing, which ensures that labelling and supporting data have been
provided and that the product has undergone and passed a review of its formulation, labelling and
instructions for use.
Enzymatic Cleaner: A cleaning agent that contains enzymes which break down proteins such as blood,
body fluids, secretions and excretions from surfaces and equipment. Most enzymatic cleaners also
contain a detergent. Enzymatic cleaners are used to loosen and dissolve organic substances.
Flash Sterilization: see Immediate Use Steam Sterilization
Hand Hygiene: A general term referring to any action of hand cleaning. Hand hygiene relates to the
removal of visible soil and removal or killing of transient microorganisms from the hands. Hand hygiene
shall be accomplished using soap and running water or an alcohol-based hand rub (ABHR).
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
One way work flow: The practice of ensuring that reprocessing work flows in one direction from the
dirtiest to the cleanest to prevent contamination.
Pasteurization: A high-level disinfection process using hot water at a temperature of 71C for a contact
time of at least 30 minutes.
Personal Protective Equipment (PPE):
against hazards.
Physical Monitor: A device that monitors the physical parameters, such as time, temperature and
pressure of a steam sterilizer.
Process Challenge Device (PCD): A test device intended to provide a challenge to the sterilization
process that is equal to, or greater than, the challenge posed by the most difficult item routinely
7
processed. Examples include BI test packs which also contain a chemical indicator, or CI test packs
which contain a Class 5 integrating indicator or an enzyme-only indicator.
Reprocessing: The steps performed to prepare used medical devices for reuse (e.g., cleaning,
8
disinfection, sterilization).
Reusable: A term given by the manufacturer of medical devices that allows it, through the selection of
9
materials and/or components, to be re-used.
Semi-critical Medical Device: Medical device that comes in contact with non-intact skin or mucous
membranes but ordinarily does not penetrate them (e.g., respiratory therapy equipment, transrectal
probes, specula). Reprocessing semi-critical devices involves meticulous cleaning followed by, at a
minimum, high-level disinfection.
Sharps: Sharps refer to any item capable of cutting or piercing the skin (e.g., injection needles, trocars,
cautery tips, scalpel blades, drill bits, saw blades, shavers). To maximize worker safety, sharps and
needles must be handled in compliance with WorkSafe BC standards. Sharps and needles deemed
single-use only by the manufacturer shall not be reprocessed.
Single-use/Disposable: A device designated by the manufacturer for single-use only. Single-use
rd
10
devices shall not be reprocessed except by an approved 3 party reprocessor.
Sterilant: A physical or chemical entity or combination of entities that has sufficient microbiocidal activity
11
to achieve sterility under defined conditions.
Sterilization: A validated process used to render a product free from viable microorganisms. This is the
level of reprocessing required for critical medical devices. Devices must be cleaned thoroughly before
sterilization can take place.
Ultrasonic Washer: A machine that cleans medical devices by the cavitations produced by ultrasound
waves.
Washer-Disinfector: A machine intended to clean and disinfect medical devices.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Preamble
About This Document
This document is intended for health care providers to ensure that the critical elements and methods of
decontamination, disinfection and sterilization are incorporated into health care facility procedures. The
document describes essential elements and methods in the safe handling, monitoring and assessment,
transportation and biological decontamination of contaminated medical devices.
The policy applies to all critical and semi-critical, single-use and multiple-use medical devices used within
health authority facilities and programs, as well as private or non-profit facilities and/or providers (e.g.,
dentists, podiatrists) providing public health care services under contract to health authorities.
Information in this document is consistent with, or exceeds, recommendations from the Public Health
Agency of Canada (PHAC). It also meets standards developed by the Canadian Standards Association
and reflects position statements of the BC Ministry of Health. As such, it shall be used as a basis for
assessing reprocessing practice by health authorities in BC.
The best practices in this document reflect the evidence and expert opinion on the reprocessing of
medical devices available at the time of writing. This document will be reviewed and updated every three
years or as new information becomes available.
Users should be cognizant of the basic principles of reprocessing and safe use of medical devices when
making decisions about new devices and equipment and methodologies that might become available.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
http://www.health.gov.bc.ca/socsec/index.html
5. Regular education (including orientation and continuing education) and support to help staff
consistently implement appropriate infection prevention and control practices is provided across the
continuum of care.
6. Effective education programs emphasize:
a) The risks associated with infectious diseases, including acute respiratory illness and
gastroenteritis;
b) Hand hygiene, including the use of alcohol-based hand rubs and hand washing;
c) Principles and components of Routine Practices as well as additional transmission-based
precautions;
d) Assessment of the risk of infection transmission and the appropriate use of personal
protective equipment (PPE), including safe application, removal and disposal;
e) Appropriate cleaning and/or disinfection of health care equipment, supplies and surfaces
or items in the health care environment
f) Individual staff responsibility for keeping clients/patients/residents, themselves and coworkers safe; and
g) Collaboration between professionals involved in Infection Prevention and Control and
Occupational Health and Safety (OHS).
NOTE: Education programs should be flexible enough to meet the diverse needs of the range of
health care providers and other staff who work in the health care setting. The local public health
unit and regional infection control networks may be a resource and can provide assistance in
developing and providing education programs for community settings.
7. Collaboration between professionals involved in OHS and Infection Prevention and Control is
promoted in all health care settings to implement and maintain appropriate infection prevention and
control standards that protect workers.
8. There are effective working relationships between the health care setting and local Public Health.
Clear lines of communication are maintained and Public Health is contacted for information and
17
advice as required and the obligations (under the Public Health Act, SBC. 2008, section 73) to
report reportable and communicable diseases are fulfilled. Public Health provides regular aggregate
reports of outbreaks of any infectious diseases in facilities and/or in the community to health care
settings.
9. Infection prevention and control guidance is required for staff support in the decision making process.
10. There are established procedures for receiving and responding appropriately to all international,
national, regional and local health advisories in all health care settings. Health advisories are
communicated promptly to all staff responsible for reprocessing medical devices and regular updates
are provided. Current advisories are available from Public Health, the Ministry of Health, Health
Canada and the PHAC websites as well as local regional infection prevention and control networks.
11. Where applicable, there is a process for evaluating PPE in the health care setting, to ensure it meets
quality standards.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
12. There is regular assessment of the effectiveness of the infection prevention and control program and
its impact on practices in the health care setting. The information is used to further refine the
18
program.
13. The BC Ministry of Health's Home and Community Care requirements shall be met.
legislative requirements for long-term care providers shall be found in:
Specific
19
All HCC residential care facilities are either licensed under the Community Care and Assisted Living Act,
or licensed or designated under the Hospital Act, and are subject to regular inspection and monitoring under
these Acts. Many facilities are also voluntarily accredited through the Canadian Council on Health Services
Accreditation.
25
The Assisted Living Registrar under the Community Care and Assisted Living Act
has a mandate to
protect the health and safety of assisted living residents. The Registrar administers the assisted living
provisions of the Act, which require assisted living operators to register their residences and meet provincial
health and safety standards. Information on the Assisted Living Registrar is available at:
http://www.hls.gov.bc.ca/assisted/mandate.html
In addition, all health authorities have operating agreements with their affiliate residential care operators
and have established performance management frameworks within the agreements that include
performance indicators against which to measure facility performance.
All long-term care providers shall also comply with all requirements outlined in the Ministrys Home and
26
27
Community Care Policy Manual. The Home and Community Care Policy Manual outlines the
Ministrys requirements for the provision of long-term care services, programs and supplies for health
authorities. There is also a range of legislation and regulation which address facility operator
requirements such as environment services (waste management,; pest control; housekeeping services;
laundry services and; maintenance services) and risk management (infection control; health and safety;
internal and external disaster planning and; monitoring, evaluating and improving quality). This legislative
28
29
framework includes the Public Health Act and Residential Care Regulations.
In regard to the legislative requirements for staff education in long-term care facilities, health authorities
establish their own policies for orientation of staff, and mandatory education programs are established by
professional licensing bodies and professional licensing bodies. Health authorities shall also require their
staff to participate in education programs on a mandatory basis.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
As such, there is range of legislative and regulatory requirements that an operator of a facility should
comply with and Licensing Officers, who are delegated by the BC Medical Health Officer are responsible
30
for ensuring that facilities meet the requirements of the Community Care and Assisted Living Act as well
as all applicable regulations.
For more information, please contact your respective health authority. Contact information for each health
authority is available at: http://www.health.gov.bc.ca/socsec/index.html.
14. Occupational Health and Safety requirements shall be met:
Health care facilities are required to comply with applicable provisions of the Workers Compensation
31
Act, RSBC 1996, and Occupational Health and Safety Regulations. Employers, supervisors and
workers have rights, duties and obligations under the Workers Compensation Act. Specific
requirements under the Workers Compensation Act are available at:
http://www.bclaws.ca/EPLibraries/bclaws_new/document/ID/freeside/96492_00.
The Workers Compensation Act places duties on many different categories of individuals associated
with workplaces, such as employers, constructors, supervisors, owners, suppliers, licensees, officers
of a corporation and workers. Additional information regarding the requirements and regulations
under the Workers Compensation Act are available at:
http://www2.worksafebc.com/Publications/OHSRegulation/WorkersCompensationAct.asp.
Specific health and safety requirements for residential facilities shall be found in the
Care Regulation, RSBC 2009, Regulation, available at:
http://www.bclaws.ca/EPLibraries/bclaws_new/document/ID/freeside/96_2009
Residential
32
In addition, the Workers Compensation Act section 115 the general duty clause, requires an employer
to take every precaution reasonable in the circumstances for the protection of a worker. There is a
general duty for an employer to establish written measures and procedures for the health and safety of
workers, in consultation with the joint health and safety committee or health and safety representative, if
any. Such measures and procedures shall include, but are not limited to, the following:
Safe work practices
Safe working conditions
Proper hygiene practices and the use of hygiene facilities
The control of infections
At least once a year the measures and procedures for the health and safety of workers shall be reviewed
and revised in the light of current knowledge and practice. The employer, in consultation with the joint
health and safety committee or health and safety representative, if any, shall develop, establish and
provide training and educational programs in health and safety measures and procedures for workers that
are relevant to the workers work.
A worker who is required by his or her employer or by the Community Care and Assisted Living
Act (CCALA) to wear or use any protective clothing, equipment or device shall be instructed and
trained in its care, use and limitations before wearing or using it for the first time and at regular
intervals thereafter and the worker shall participate in such instruction and training. The employer is
reminded of the need to be able to demonstrate training, and is therefore encouraged to document
the workers trained, the dates training was conducted, and materials covered during training. Under
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
the Workers Compensation Act, a worker should work in compliance with the Act and its regulations,
and use or wear any equipment, protective devices or clothing required by the employer.
For more information, please contact your local WorkSafeBC office. A list of local regional
WorkSafeBC offices is available at http://www.worksafebc.com/contact_us.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
I.
General Principles
This document applies to critical and semi-critical reusable medical devices, be they
purchased, loaned, physician/practitioner-owned, research devices or obtained by any other
method and regardless of where reprocessing occurs.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Staff
All reprocessing of medical devices, regardless of source, shall meet best practices whether the device is
purchased, loaned, physician/practitioner-owned, used for research, or equipment obtained by any other
means, and regardless of where reprocessing occurs.
A. Device Purchases
The administration of the health care setting is responsible for verifying that any product used in the
provision of care to clients/patients/residents is capable of being cleaned, disinfected and/or sterilized
according to the most current standards and guidelines from the Canadian Standards Association (CSA),
the PHAC/Health Canada as well as these BC Ministry Best Practices. The issuing of a purchase order is
a useful point of control for ensuring that appropriate review of the device has taken place prior to
purchase.
Equipment that is used to clean, disinfect or sterilize (e.g., ultrasonic washers, pasteurizers, washerdisinfectors, automated endoscope reprocessors / AERs, sterilizers) shall also meet standards
38
established by the CSA , Health Canada/PHAC and the requirements of this document.
Decision-making prior to purchasing reusable medical devices and reprocessing equipment shall involve
representatives from the departments in the health care setting that will use, reprocess and maintain the
39,40
items and should include, as appropriate
:
a) Medical Device Reprocessing/Sterile Processing (required);
b) Unit/department that will use the device;
c) Risk Management;
d) Infection Prevention and Control (required);
e) Occupational Health and Safety;
f) Support services;
g) Physical plant/maintenance;
h) Biomedical Engineering; and
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
i)
Reprocessing staff, Infection Prevention and Control, Biomedical Engineering and Occupational Health
and Safety shall make recommendations regarding the ability to achieve the appropriate level of
41
reprocessing required for the device according to Spauldings criteria (see Table 1) and the suitability of
the device for purchase, after reviewing:
a) The manufacturers instructions for use (MIFU);
b) Applicable CSA standards regarding the device;
c) Health Canada/PHAC guidelines regarding the device; and
d) The Ministrys Best Practices Guidelines for Cleaning, Disinfection and Sterilization of Critical and
Semi-Critical Medical Devices
Prior to purchase of the device, all parties involved should
be in agreement that the procedure for reprocessing the
device satisfies the required criteria and is achievable in
the health care setting. If such a process cannot be
defined, consideration should be given to alternate devices
that can be adequately reprocessed.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
b) Determine if there are any limitations and restrictions on reprocessing the device and specify the
number of reprocessing cycles that can be tolerated;
c) Specify the requirements for the preparation at the point of use of the medical device;
d) Specify the requirements for the preparation of the medical device prior to cleaning;
e) Specify a validated manual cleaning method and at least one validated automated method unless
the medical device cannot withstand this process;
f) Specify a validated non-automatic method of disinfection and at least one validated automated
method using a washer disinfector unless the medical device cannot withstand this process;
g) Specify, if necessary, a validated method of drying;
h) Specify inspection, maintenance and testing methods required at any stage of processing;
i) Specify a method of packaging that is compatible with the stated sterilization process and the
medical device;
j) Specify a validated sterilization method unless the medical device cannot withstand this process;
k) Specify any limitation for the time or conditions of storage of the medical device prior to use; and
l) Validate that any process identified in instructions for use are capable of reprocessing the medical
device for its intended use.
A valid medical device license issued by the Therapeutic Products Directorate of Health Canada
45
[http://www.mdall.ca/] or provided by the manufacturer shall be available for all medical devices that are
class II and higher. Failure to comply with licensing could result in litigation under the Medical Devices
46
Regulations section of the Food and Drugs Act.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
i)
ii)
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
6. Newly purchased, non-sterile critical and semi-critical medical devices shall first be
inspected and reprocessed according to their intended use prior to being put into
circulation.
7. The organization shall develop and maintain policies and procedures that apply to the
sending, transporting, receiving, handling and processing of loaned, shared and leased
medical devices, including endoscopes.
8.
9. Surgical devices at risk for CJD contamination shall be managed following Health
Canada/PHAC infection control guideline, Classic Creutzfeldt-Jakob Disease in Canada.
51,52
Decontamination sinks :
a) Shall be designed and arranged to facilitate soaking, washing and rinsing of devices with minimal
movement or delay between steps;
| Page 26 of 136 pages
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
b)
c)
d)
e)
f)
Refer to Appendix C, Recommendations for Physical Space for Reprocessing, for details
regarding reprocessing area space requirements.
B. Air Quality
The Occupational Health and Safety Regulation respecting control of exposure to biological and chemical
agents made under the Workers Compensation Act provides occupational exposure limits such as ceiling
55
exposure value (CEV) for chemical agents (e.g., glutaraldehyde).
A CEV is the maximum airborne
concentration of a chemical agent to which a worker is exposed at any time. If control measures are not
available during reprocessing involving a chemical agent, air sampling shall be required to ensure that the
regulated limit has not been exceeded for the chemical being used.
The health care setting should have air changes; temperature and humidity appropriate to the
process/product being used (refer to CSA standards and manufacturers recommendations for products).
In health care settings where there are dedicated medical device reprocessing departments, in soiled
areas negative pressure relative to clean areas shall be maintained, and positive pressure shall be
56
maintained in clean areas. Pressure should be monitored.
Refer to Appendix C, Recommendations for Physical Space for Reprocessing, for specific
information regarding reprocessing area ventilation, temperature and humidity requirements
C. Water Quality
The quality of the water supply used for reprocessing shall be known and checked as required. Policies
shall be developed to address known problems. There should be written reprocessing contingency plans
in place that address loss of potable water, boil water advisories and other situations where the water
supply becomes compromised.
Refer to Appendix C, Recommendations for Physical Space for Reprocessing, for information
regarding reprocessing area water quality requirements,
57
AMMI TIR 34 (2007), Water for the reprocessing of medical devices.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Refer to the MOHLTCs Best Practices for Environmental Cleaning for Prevention and Control of
Infections in All Health Care Settings for guidance regarding cleaning in reprocessing areas,
available at:
http://www.health.gov.on.ca/english/providers/program/infectious/diseases/ic_enviro_clean.html.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
63
Reprocessing policies and procedures shall include, but are not limited to, the following :
a) Responsibilities of management and staff;
b) Qualifications, education, training and competency assessment of staff involved in reprocessing;
c) Infection prevention and control activities;
d) Worker health and safety activities;
e) Preventive maintenance requirements with documentation of actions;
f) Written protocols for each component of the cleaning, disinfection and/or sterilization process that
are based on the manufacturers recommendations and established guidelines for the intended
use of the product;
g) Provision for regular review of policies and procedures with updating as required e.g. every 3
years as per CSA Z314.3-09;
h) Documentation and record maintenance for each critical process (e.g., high level disinfection,
sterilization);
i) Management and reporting of incidents where client/patient/resident or staff safety may have
been compromised ;
j) Requirements for internal or external subcontractors, if applicable; and
64
k) Written procedures for adverse events
o See Section II, 13, Quality Assurance, for more information about adverse events and a
recall procedure.
Summary of Section 3 Recommendations
15. The health care setting shall, as a minimum, have policies and procedures for all aspects of
reprocessing based on CSA standards, 65,66 these BC Ministry Best Practice Guidelines, and
67
the PHAC/Health Canada guidelines .
16. All policies and procedures for reprocessing medical devices require review by an
individual with medical device reprocessing expertise. Other stakeholders shall be
consulted as required (e.g., Infection Prevention and Control (IPC) practitioners, Health
Shared Services BC (HSSBC), Risk Management)
17. A procedure shall be established for the management of adverse reprocessing events.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Reprocessing technicians who routinely perform medical device reprocessing activities shall, at a
minimum, have successfully completed a recognized medical device reprocessing technician educational
program.
a)
b)
Where attaining the minimum educational requirement is not possible due to program
availability, it is recommended that personnel who routinely perform medical device
reprocessing activities successfully complete CSAs Certified
It is strongly recommended that
Medical Device Reprocessing Technicians program or
re-certification be obtained every
equivalent.
five years.
It is strongly recommended that re-certification be obtained
every five years.
The policies of the health care setting shall specify the requirements for, and frequency of, education and
training as well as competency assessment for all personnel involved in the reprocessing of medical
devices and will ensure that:
a) All staff who are primarily involved in reprocessing obtain and maintain their qualification;
b) There is a process in place to ensure continued competency, including continuing education
71
provided at regular intervals and periodic competency assessment ; and
72
c) All orientation, training and continuing education is documented.
Summary of Section 4 Recommendations
18. MDR Managers accountable for reprocessing shall have demonstrated knowledge of
reprocessing practices and infection prevention and control principles as they relate to
medical device reprocessing.
19. All staff, including supervisors, involved in the reprocessing of medical devices should be
supervised and shall be qualified through education, training and experience in the
functions they perform.
20. Reprocessing technicians who routinely perform medical device reprocessing activities
shall, at a minimum, have successfully completed a recognized medical device
reprocessing technician educational program.
21. Any individual involved in any aspect of reprocessing shall obtain education, orientation
and training specific to the function they perform/medical device to be reprocessed (e.g.,
medical imaging technologists, respiratory technicians and staff in endoscopy, dental,
podiatry, residential care, and physician offices).
22. The policies of the health care setting shall specify the requirements for, and frequency of,
education and training as well as competency assessment for all personnel involved in the
reprocessing of medical devices.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
c) Chemicals are labelled, stored and handled appropriately, and Material Safety Data Sheets
(MSDS) are readily available as required by the Workplace Hazardous Materials Information
77
System (WHMIS), R.R.O. 1990, Reg. 860 Amended to O. Reg. 36/93 ;
d) An eyewash fountain is installed near to where chemicals are stored or used to treat the eyes
78
after contact with a biological or chemical agent ; and
e) Personal protective equipment appropriate to the task is available and used.
Information on WHMIS is available from the Health Canada website at: http://www.hc-sc.gc.ca/ewhsemt/occup-travail/whmis-simdut/index_e.html].
The federal Hazardous Products Act and the pursuant Controlled Products Regulation, which apply to
suppliers, define which materials (i.e., controlled products) are included in the Workplace Hazardous
Materials Information System (WHMIS) and what information suppliers should provide to employers for
controlled products used in the workplace.
The Workers' Compensation Board administers the requirements of the Hazardous Products Act in BC
under section 114 of the Workers Compensation Act, and WorkSafeBC officers enforce federal
requirements on suppliers under the Hazardous Products Act.
A. Routine Practices
79, 80
Routine practices
shall be part of all staff education and training to prevent exposure to body
substances. Procedures shall be in place for immediate response to staff exposure to blood and body
81
fluids or injury from sharp objects. All staff that reprocess should be immune to Hepatitis B or receive
82, 83, 84
Hepatitis B immunization.
Routine practices in reprocessing areas include:
85,86;
a) A dress code for all reprocessing areas
87,88;
b) A policy to control traffic in reprocessing areas
c) A policy that prohibits eating/drinking, storage of food, smoking, application of cosmetics or lip
89, 90
balm and handling contact lenses in the reprocessing area
;
1
d) Personal effects, including food and drink, shall not be brought into the reprocessing area ;
e) Hand hygiene facilities located at all entrances to, and exits from, reprocessing areas and faucets
91, 92
should be supplied with foot-, wrist- or knee-operated handles or electronic sensors
;
93, 94, 95
f) Hand hygiene training for reprocessing staff
which includes:
i)
Hands shall be cleaned before beginning work, before breaks and upon completion of
work; after removing gloves; and whenever hands are contaminated;
ii)
If there is visible soil on the hands, hand hygiene shall be performed with soap and water.
If there is no visible soil on the hands, staff shall use either soap and water or an alcoholbased hand rub (ABHR); and
iii)
Hand or arm jewellery, external body piercings that cannot be covered, or nail
enhancements including nail polish, shall not be worn.
g) Provision for, and wearing of, appropriate PPE for all reprocessing activities.
More information on Routine Practices shall be found in the PHAC following publication:
Routine Practices and Additional Precautions for Preventing the Transmission of Infection in
Health Care, available at: http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/99pdf/cdr25s4e.pdf
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Additional information on PPE may be found in the MOHLTCs Routine Practices and Additional
103
Precautions for All Health Care Settings , available at:
http://www.health.gov.on.ca/english/providers/program/infectious/diseases/ic_routine.html.
D. Work Restrictions
105
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
24. There is a policy that prohibits eating/drinking, storage of food, smoking, and application of
cosmetics or personal effects in the reprocessing area.
25. Appropriate personal protective equipment (PPE) shall be worn for all reprocessing
activities.
26. All staff working in reprocessing shall be offered Hepatitis B immunization unless they have
documented immunity to Hepatitis B.
27. Measures and procedures shall be written to prevent and manage injuries from sharp
objects.
28. Measures and procedures shall be in place for immediate response to worker exposure to
chemicals as well as blood and body fluids.
29. Occupational Health and Safety for the health care setting should review all protocols for
reprocessing medical devices to verify that worker safety measures and procedures are in
place.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Semi-critical medical devices owned by the client that are re-used in their home shall be adequately
cleaned prior to reuse. Home health care agencies may consider re-using single-use semi-critical
medical devices for a single client in their home when reuse is safe. Critical medical devices owned by
clients cannot be reprocessed safely as sterilization cannot be achieved in the home environment.
Therefore, critical medical devices remain single use in the home and shall be disposed of after use.
Refer to CSA Z314.8-09 Annex J for further information regarding difficult to cleaning medical devices.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
e) Sterile and soiled devices shall not be transported together (i.e., on the same cart) due to the risk
of cross-contamination.
D. Cleaning
Cleaning shall be done manually or using mechanical cleaning machines (e.g., washer-disinfector,
ultrasonic washer) after gross soil has been removed. Automated machines may increase productivity,
116
improve cleaning effectiveness and decrease staff exposure to blood and body fluids.
Manual cleaning
may be required for delicate or intricate items.
Devices shall
manufacturer.
a.
b.
c.
d.
The device manufacturers cleaning instructions shall be followed, including specifications for detergent
type, water temperature and cleaning methods. The following procedures are included in the cleaning
process:
118
a) Manual Cleaning
Ensure that the device to be cleaned is compatible with the chemical solutions that are
being used;
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
b) Mechanical Cleaning
Whenever possible, clean devices by mechanical means:
i)
Use mechanical washers in accordance with the manufacturers instructions;
ii)
Manually clean heavily soiled devices before mechanical cleaning if necessary;
iii)
Ensure that the device to be cleaned is compatible with the mechanical cleaning
equipment, cycle parameters and chemical solutions that are being used;
iv)
Ultrasonic washers are strongly recommended for any semi-critical or critical medical
device that has joints, crevices, lumens or other areas that are difficult to clean.
The manufacturers instructions shall be followed for use and routine cleaning
and maintenance of the ultrasonic washer.
Devices shall be completely immersed in the cleaning solution/bath.
After cleaning, devices shall be rinsed thoroughly prior to further reprocessing
The ultrasonic solution shall be changed at least daily or more frequently if it
becomes visibly soiled or if the manufacturers instructions specify more frequent
changes.
v)
Washer-disinfectors are strongly recommended for medical devices that can withstand
mechanical cleaning, to achieve the required exposure for cleaning and to reduce
potential risk to personnel. When used:
Washer-disinfectors shall meet the requirements of CSA and ISO 15883.
The manufacturers instructions shall be followed for the use, preventative and
routine maintenance, cleaning, and calibration of the washer-disinfector.
c) Care of Cleaning Tools
i)
Follow manufacturers instructions for use, cleaning, disinfection, drying, and storage of
cleaning tools 121;
ii)
Inspect brushes and other cleaning equipment for damage after each use, and discard if
necessary122; and
iii)
The use of single-use cleaning tools is recommended. If reusable tools are used, they
shall be disinfected at least daily.
d) Rinsing
Rinsing following cleaning is necessary to remove loosened soil and residual detergent:
i)
Rinse all devices thoroughly after cleaning with water to remove residues which might
react with the disinfectant/sterilant; and
ii)
Perform the final rinse of lumens of intravascular/intrathecal devices with commercially
prepared sterile, pyrogen-free water (note: distilled water is not necessarily sterile or
123
pyrogen-free) .
e) Drying
124
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Drying is an important step that prevents dilution of chemical disinfectants which may render
them ineffective and prevents microbial growth:
i)
Follow the manufacturers instructions for drying of the device;
ii)
Devices shall be air-dried or dried by hand with a clean, lint-free towel;
iii)
Dry lumens with compressed medical grade or HEPA-filtered air at a pressure specified
by the device manufacturer. Use a regulator to control pressure; and
iv)
Dry stainless steel devices immediately after rinsing to prevent spotting.
Many factors
affect the efficacy of disinfection and sterilization, particularly when chemical
reprocessing is used. These factors include:
a) Cleanliness of the surface of the device:
i) Bioburden
| Page 37 of 136 pages
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
ii)
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
B. Product selection
The reprocessing method and products required for medical devices will depend on the intended use of
the device and the potential risk of infection involved in the use of the device. The process and products
used for disinfection and/or sterilization of medical devices shall be compatible with the devices:
a) Compatibility of the device with the disinfection/sterilization process, shall be determined by the
manufacturer of the device; and
b)
All medical devices that will be purchased and will be reprocessed shall have written devicespecific manufacturers reprocessing instructions. If disassembly or reassembly is required,
detailed instructions with pictures should be included. Staff training should be provided on these
processes before the medical device is placed into circulation.
C. Terminal Reprocessing
The level of terminal reprocessing required by medical devices is based on the classification system
133
developed by Spaulding . It divides medical devices into three categories, based on the client/patient/
residents risk of infection due to contact with various types of devices.
Table 1: Spaulding's Classification of Medical Devices and Required Level of
Processing/Reprocessing
Classification
Definition
Level of
Processing/Reprocessing
Examples
Critical Device
Cleaning followed by
Sterilization
Surgical instruments
Biopsy instruments
Foot care equipment
Cystoscopes
Semi-critical
Device
Respiratory therapy
equipment
Anaesthesia
equipment
Tonometer
Cystoscopes
Noncritical
Device
ECG machines
Oximeters
Bedpans, urinals,
commodes
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
D. Reprocessing Products
Products used for any/all stages in reprocessing (e.g. disinfection, sterilization) should be:
a) Appropriate to the level of reprocessing that is required for the use of the medical device; and
b) Approved by the committee responsible for product selection, by an individual with reprocessing
expertise and by an individual with infection prevention and control expertise.
Summary of Section 7 Recommendations
40. Procedures for disinfection and sterilization should include statements and information
regarding the type, concentration and testing of chemical products; duration and
temperature of exposure; and physical and chemical properties that might have an impact
on the efficacy of the process. These procedures should be readily accessible to staff
performing the function.
41. Products used for any/all stages in reprocessing should be approved by the committee
responsible for product selection, by an individual with reprocessing expertise and by an
individual with infection prevention and control expertise
42. The reprocessing method and products required for medical devices will depend on the
intended use of the device and the potential risk of infection involved in the use of the
device.
43. Products used for disinfection and sterilization should be appropriate to the level of
reprocessing that is required for the use of the medical device.
44. The process and products used for disinfection and/or sterilization of medical devices
shall be compatible with the devices.
45. The manufacturer shall provide written, validated, device specific information regarding
the safe and appropriate reprocessing of the medical device.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
When selecting a disinfectant for reprocessing medical devices in the health care setting, consider :
a) The requirement for disinfectants to have a Drug Identification Number (DIN) from Health
137
Canada ;
b) Efficacy for the intended use;
c) Compatibility with the device;
d) The intended end use of the devices;
e) The methods to be used for monitoring the product concentration, efficacy, temperature, and
contact time;
f) Recommendations for rinsing (e.g., water quality, volume, time);
9
g) Safety for use, with minimal toxic and irritating effects to/for staff ;
h) Environmental safety, biodegradability and disposal;
i) Manufacturers instructions for use (e.g., contact time, concentration/dilution, water
requirements); and
j) Method of use e.g. manual immersion, automated reprocessor.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
The manufacturers recommendations for chemical disinfectants shall be followed pertaining to:
a) Usage - disinfectant manufacturers shall supply recommended usage for the disinfectant to
ensure that it is compatible with the medical devices on which it will be used;
b) Contact time;
c) Shelf life;
d) Storage;
e) Appropriate dilution and temperature; and
f) Environmental and personnel safety e.g. required PPE, ventilation
If a disinfectant manufacturer is unable to provide compatibility information specific to the medical device,
information may be obtained from Health Canadas drug information website, available at: http://www.hcsc.gc.ca/dhp-mps/prodpharma/databasdon/index-eng.php.
The process of high-level disinfection requires monitoring and documentation:
a) Chemical test strips shall be used to determine whether a minimally effective concentration
(MEC) of active ingredients is present because of the potential for dilution from repeated reuse:
i) The frequency of testing is determined by the MIFUs;
ii) Chemical test strips shall be checked each time a new package/bottle is opened to verify
their efficacy according to the MIFUs;
iii) Test strip results shall not be used to extend the use of a disinfectant solution beyond the
in-use expiration date; and
iv) Disinfectant solutions shall not be used and shall be discarded if MEC test strip fails prior
to the in-use expiration date.
b) A permanent record of high-level disinfection shall be completed and retained according to the
138
policy of the facility ; this record shall include, but not be limited to:
i)
Name of disinfectant, lot number and expiry date;
ii)
The identification of the device to be disinfected;
iii)
Date and time that the device was disinfected;
iv)
Concentration, contact time, and temperature of the disinfectant used in each process;
v)
Result of each MEC testing of the disinfectant; and
vi)
The name of the person completing the reprocessing.
Disinfection practices shall be assessed on a regular basis and a quality improvement process should be
in place to deal with any irregularities/concerns resulting from the assessment.
Prepared solutions shall not be topped up with fresh solution.
139
Rinsing of medical devices following manual chemical disinfection requires three separate water rinses as
outlined in the chemical and/or device MIFU. The quality of the water (e.g., potable, sub-micron filtered or
sterile) will depend on the intended use of the medical device being reprocessed.
Drying of semi-critical medical devices that have been disinfected and rinsed with pyrogen free water
140
shall be completed using medical grade air or HEPA filtered air .
If manual disinfection is performed, the container used for disinfection shall be kept covered, whenever
141
possible, during use
and washed, rinsed and dried when the solution is changed.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Due to the complexity of their design, flexible fibreoptic and video endoscopes (semi-critical
144 , 145
endoscopes) require meticulous cleaning and handling.
B. Physical Space
The endoscope reprocessing area should be physically separate from patient care areas and procedure
rooms. The decontamination area should be separate from clean areas.
149,150,151
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
C. Cleaning Procedures
Each health care setting in which endoscopic procedures are performed should have written detailed
152
procedures for the pre-cleaning (e.g., at the bedside), cleaning and handling of endoscopes.
Endoscope pre-cleaning should take place immediately following completion of the clinical procedure,
as soil residue in endoscope lumens dries rapidly, becoming very difficult to remove.
153
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
g) Use irrigation adaptors or manifolds that are recommended by the manufacturer to facilitate
cleaning;
h) Endoscopic equipment shall be rinsed and excess water removed prior to sterilization or dried
prior to disinfection;
i) Identify damaged endoscopes and immediately remove from service; and
j) Discard enzymatic cleaner and rinse water after each use.
Manual Cleaning
Follow the endoscope manufacturers recommendations for model-specific endoscope cleaning protocols
and for the cleaning products to be used.
Unless otherwise validated by the endoscope reprocessor manufacturer and by third party research,
endoscopes shall be manually cleaned after each use. The following steps should be included in the
158,159,160
cleaning procedure:
a) Use a detergent that is compatible with the endoscope and accessories
b) Use fresh, low-sudsing enzymatic cleaning solution and rinse water for each endoscope
c) Prepare and use the enzymatic cleaning solution according to manufacturers instructions for use
e.g. concentration, temperature
d) Completely immerse the endoscope in the enzymatic solution for cleaning and allow the
appropriate time to soak. Clean the exterior with a soft brush or a lint-free product
e) Ensure that brushes used for cleaning the channels are of an appropriate size, and are inspected
before and after each use
f) Flush/suction and brush all channels and lumens while the endoscope is completely immersed.
Keep the bending section straight to avoid damaging the scope
g) Use only those irrigation adaptors or manifolds that have been validated by the endoscope
manufacturer and the manufacturer of the automated reprocessor. Use these according to the
manufacturers instructions
h) Disconnect and disassemble (as far as possible) all endoscope components e.g. air/water and
suction valves
i) Soak and manually clean all endoscope components in an enzymatic solution
j) Rinse the endoscopes and accessories in fresh water
k) Ensure that the endoscope and accessories are dried prior to sterilization, or that the excess
water is removed prior to disinfection
l) Use disposable cleaning items, or if reusable items are used, ensure that they are thoroughly
cleaned and high-level disinfected/sterilized between uses
Remove damaged endoscopes from service
D. Disinfection or Sterilization
Procedures for disinfection or sterilization of endoscopes should ensure that a minimum of high-level
disinfection is used for all endoscopes and their accessories, excluding biopsy forceps and brushes which
161
require sterilization.
The following steps should be included in the disinfection/sterilization
162,163,164
procedure:
a) Choose a disinfectant or sterilant that is compatible with the endoscope;
b) Monitor the efficacy of the disinfectant or sterilant as per the manufacturers instructions;
c) Maintain a written log of monitored test results;
d) Do not use disinfectants or sterilants past their expiry date, shelf life, in-use life, or if the MEC
fails;
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
e) Carefully follow the manufacturers directions regarding the temperature, duration, and contact
time for the disinfectant or sterilant;
f) Completely immerse the endoscope and endoscope components in the high-level disinfectant or
liquid chemical sterilant and ensure all channels are perfused; and
g) Following disinfection or liquid chemical sterilization, rinse the endoscope and flush the channels
with sub-micron filtered or sterile water.
Disposable sheaths/condoms placed over the endoscope reduce the numbers of microorganisms on the
scope but do not eliminate the need for cleaning/disinfection/sterilization between uses.
Written procedures should be based on the AER manufacturers instructions for use and shall:
a) Ensure that the endoscope and endoscope components e.g. channel connectors or caps, are
validated for reprocessing in the AER;
b) Ensure that the connectors are clearly labeled to indicate the appropriate connection site on the
AER and the endoscope. Connectors shall be labeled to clearly indicate the:
Endoscope manufacturer;
Model for which they are validated for use; and
Connection ports for the endoscopes and the AER.
The type of chemical and how it is diluted/dispensed can vary with the automatic endoscope reprocessing
system. Some chemicals are ready to use and some require dilution or activation. Chemicals can be
single-use or reusable.
The AER manufacturers instructions for the system shall describe the:
(a) Medical devices that have been validated for reprocessing in the system;
(b) Types of HLDs that have been validated for use in that specific system; and
(c) Conditions under which those HLDs will be used. These conditions should include, but are not
limited to:
(i) Contact method (e.g., complete immersion or spray);
(ii) Preparation instructions for the system. This can include directions regarding device
connections and device positioning;
(iii) Preparation instructions for the disinfectant;
(iv) In-use requirements such as contact time, temperature, and concentration
(v) Monitoring methods;
(vi) Rinsing methods. Sub-micron/bacteria free water is preferred for the final rinse.
(vii) Chemical spill procedure; and
(viii) Contingency plan for water advisories.
If the AERs irrigation adaptors or manifolds do not flush liquid through the elevator wire channel in a
duodenoscope, the channel should be manually cleaned and disinfected according to the instructions
provided by the scope manufacturer.
Implement and document preventive maintenance program(s) for the AER(s).
F. Drying and Storage of Endoscopes and their Attachments after High Level Disinfection
Steps in the final drying of semi-critical endoscopes should include:
166
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
170,171
Bronchoscopes that are wrapped and sterilized have an indefinite shelf life. Bronchoscopes that have
been immersed in a liquid chemical disinfectant or sterilant but are not used on a routine bases, should
172
be reprocessed immediately prior to use
G. Accessories
Endoscopic accessories (e.g., biopsy forceps and brushes) that break the mucosal barrier shall be
173
sterilized before each use:
a) Because of the difficulty cleaning biopsy forceps/brushes, it is strongly recommended that
disposable items be used;
b) If reusable biopsy forceps/brushes are used, they should be meticulously cleaned (e.g. ultrasonic)
prior to sterilization; and
c) The water bottle, cap and connecting tube, shall be cleaned and at least HLD daily. Sterilization
is required prior to each Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure
174
and prior to any procedure that invades sterile tissue.
Sterile water shall be used to fill the
water bottle.
H. Documentation
An accurate, permanent record of endoscope use and reprocessing should link endoscopes to
clients/patients/residents in the event of follow-up of an adverse event:
a) For each procedure, document the client/patient/residents name and record number, the date
and time of the procedure, the type of procedure, the endoscopist, and the serial number or other
175, 176
identifier of the endoscope to assist in investigation;
b) For each endoscope reprocessed, document the scope ID, the reprocessing equipment ID, date
and time, HLD or sterilant contact time, MEC test results or chemical indicator result, and the
177, 178
person(s) who completed the reprocessing
; and
179
c) Retain records according to the policy of the facility.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
For more information regarding reprocessing of endoscopes, see the CSAs Z314.8-08
180
Decontamination of Reusable Medical Devices, Section 13.
10.
Sterilization is the elimination of all disease-producing microorganisms, including bacterial spores (e.g.
Clostridium and Bacillus species). Prions are not
The preferred method for
| Page 49 of 136 pages
sterilization of heat-resistant
medical devices is pre-vacuum
steam sterilization.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
susceptible to routine sterilization. Sterilization is used on critical medical devices and, whenever
possible, semi-critical medical devices. The preferred method for sterilization of heat-resistant
critical devices is steam sterilization (pre-vacuum sterilization is preferred).
For devices that cannot withstand steam sterilization, some examples of chemical sterilants include:
a) Hydrogen peroxide gas plasma;
b) 0.2% peracetic acid;
c) 7% accelerated hydrogen peroxide;
d) 100% ethylene oxide; and
e) Ozone.
For processes for liquid chemical sterilant manual soaking, follow section 9.D.
A. Sterilization Process
181
Medical devices that have contact with sterile body tissues or fluids are considered critical items. All
182,183,184,185
critical medical devices shall be cleaned and then sterilized,
because microbial contamination
could result in disease transmission. Critical items include, but are not limited to, surgical instruments,
implants, foot care equipment, endoscopes that enter sterile cavities and spaces, colposcopy equipment,
biopsy forceps and brushes, eye and dental instruments.
Whenever possible, semi-critical medical devices should be sterilized. (Semi-critical medical devices
186
have contact with non-intact skin or mucous membranes but do not penetrate them. ) When sterilization
187
is not possible, semi-critical devices shall be cleaned, followed by high-level disinfection.
Health care settings shall have written policies and procedures for sterilization processes that:
188, 189, 190
a) Follow the principles of infection prevention and control as set out in CSA standards,
BC
191
Ministry Best Practice Guidelines and PHAC guidelines ;
b) Follow manufacturers instructions for installation, operation, cleaning and preventive
maintenance of the sterilization equipment;
c) Follow manufacturers instructions for cleaning and preparation of the medical device. The
instructions shall be validated, written and device specific; and
d) Describe the preparation of devices to be sterilized (i.e., disassembly, cleaning, drying,
192,193,194
inspection, lubrication, wrapping, sealing and labelling)
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
The manufacturers instructions for installation, operation and ongoing maintenance of steam sterilization
equipment shall be followed.
For each cycle, the sterilization time and temperature shall be monitored and recorded.
Monitoring of the sterilization cycle shall include:
Biological.
There are several types of steam sterilizers that utilize different methods to remove air from packages and
the chamber. They are dynamic air removal (prevacuum), gravity, and steam-flush pressure-pulse
sterilizers.
Prevacuum sterilizers:
Use a vacuum pump or water ejector to remove air from the chamber and packaged devices
during the preconditioning phase and prior to sterilization;
Operate at 132C to 135C.
Gravity sterilizers:
Use gravity air displacement to remove air from the sterilizer chamber and packaged devices;
Operate at 121C or higher.
Steam-flush pressure-pulse:
Use a repeated sequence of a steam flush and pressure pulse to remove air from the chamber
and packaged items;
Operate at 121C to 123C, 132C to 135C or 141C to 144C.
Steam sterilizers vary in chamber size from small table top models to large floor loading models. The
recommended practices described in this guideline shall apply to all types (and sizes) of steam sterilizers,
including table top sterilizers.
Users shall obtain written validated device specific instructions from the device manufacturer and sterilizer
efficacy testing from the sterilizer manufacturer when utilizing the steam sterilization method.
i. Device Preparation
Devices shall be prepared for sterilization in the following manner:
Clean, with excess water removed;
Jointed instruments in the open or unlocked position;
Multi-piece or sliding pieces disassembled unless otherwise indicated by the device
manufacturer;
Devices with concave surfaces that will retain water are placed in such a manner that condensate
does not collect;
Instruments with lumens moistened with distilled water immediately prior to sterilization;
Heavy items arranged as to not damage lighter more delicate items; and
Sharp instruments with tips protected.
| Page 51 of 136 pages
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
ii. Packaging
Packaging materials for steam sterilization shall:
Be validated for steam sterilization;
Contain no toxic ingredients or dyes;
Be capable of withstanding high temperatures;
Allow air removal from packages and contents;
Permit sterilant contact with the package contents;
Permit drying of the package and contents;
Prevent the entry of microbes, dust and moisture during storage and handling;
Have a proven and tamper-proof seal;
Withstand normal handling and resist tearing or puncturing; and
Allow for aseptic presentation.
Packaging manufacturers instructions for use shall be followed.
195
The total weight of instrument sets and their packaging shall not exceed 10 kg.
The total weight of a wrapped basin set shall not exceed 3 kg.
196
iii. Loading
Steam sterilizers shall be loaded in the following manner to ensure sterilant contact and penetration:
Package placement to avoid overloading;
Non-perforated tray and container placed on their edge;
Packages away from chamber walls;
Concave devices on an angle to avoid condensate pooling;
Textile packs perpendicular to the sterilizer cart shelf;
Steri-peel on its edge with multiple packages being placed paper to plastic; and
Rigid containers shall not be stacked unless validated by the manufacturer for that configuration.
The operator responsible for loading and initiating the cycle shall be documented.
iv. Unloading
Upon completion of the cycle, the operator responsible for unloading the sterilizer shall:
Review the sterilizer printout for the following:
o Correct sterilization parameters;
o Cycle time and date; and
o Cycle number matches the lot control label for the load.
Verify and initial that the correct cycle parameters have been met;
Examine the load items for :
o Any visible signs of moisture; and
o Any signs of compromised packaging integrity.
Printed records of each cycle parameters (i.e., temperature, time) shall be retained in accordance with the
18
health care settings requirements.
| Page 52 of 136 pages
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
v. Load Cool-Down
Upon removal of the sterilized load the operator shall:
Visually verify the results of the external chemical indicators;
Allow the load to cool to room temperature. The amount of time for cooling depends on the
Devices that have been sterilized; and
Ensure cool-down occurs in a traffic free area without strong warm or cool air currents.
vi. TroubleshootingWet Pack Problems
Packages are considered wet when moisture in the form of dampness, droplets or puddles are found on
or within a package. There are two types of wet packs; those with external wetness and those with
internal wetness. Sterility is considered compromised and the package contents considered contaminated
when wet packs are found. There are several causes of wet packs. The following is a list of possible
causes:
Packages are improperly prepared or loaded incorrectly;
Condensation dripping from the sterilizer cart shelf above the item;
Condensation dripping from rigid sterilization containers placed above absorbent packaging;
Condensate blowing through the steam lines into the sterilizer chamber;
Instrument or basin sets that are too dense or lack absorbent material to wick moisture away;
Linen packs wrapped too tightly; and/or
Sterilization containers with a low metal-to-plastic ratio.
For a more information on troubleshooting wet packs, refer to:
www.health.qld.gov.au/chrisp/sterilising/section_appendix.pdf
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Procedures for Immediate Use Steam Sterilization shall include daily biological indicator testing of the
sterilizer used for the cycles.
Immediate Use Steam Sterilization cycles shall be documented so that:
Devices can be traced to the patient should there be an adverse event.(e.g. failed BI);
Inventory requirement can be monitored; and
Ways to reduce the need for Immediate Use Steam Sterilization can be identified.
Documentation shall contain the reason for Immediate Use Steam Sterilization, description of the
device, the patients name, the surgeons name, and the time and date of the procedure. A report shall be
prepared, reviewed, and maintained in accordance with the facilitys risk management policy.
For more information regarding the use and requirements of Immediate Use Steam Sterilization, refer to
CSA Standard Z314.3-09, Effective Sterilization in Health Care Facilities by the Steam Process [Section
197
13].
viii. Table Top Sterilizers
For detailed information on table top sterilizers, refer to CSA Plus 1112 Infection prevention and control
198
in office based health care and allied service (Section 4.4).
and AAMI ST 55: 2010 Table top steam
199
sterilizers.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Liquid chemical sterilization (immersion) is not recommended as a best practice for sterilization of medical
devices. Refer to Appendix D, Advantages and Disadvantages of Currently Available Sterilization and
High Level Disinfection Options for further information.
However, if liquid chemical sterilization is required, see Section 9.D for guidance.
Ethylene Oxide
In addition to the information found in Appendix D Advantages and Disadvantages of Currently Available
Sterilization and High Level Disinfection Options, users of ethylene oxide should know that it is a
200
designated substance under the Workers Compensation Act.
Facilities that use ethylene oxide for
sterilization shall comply with the workplace health and safety regulations as well as guidelines from
201
Environment Canada.
Medical devices sterilized with ethylene oxide shall be thoroughly aerated prior to handling or use
according to the device manufacturers recommendations.
The aeration cycle shall not be interrupted for any reason e.g. to retrieve items for use.
202
For more information regarding sterilizing with ethylene oxide, refer to the CSAs Z314.2-09
203
Effective Sterilization in Health Care Facilities by the Ethylene Oxide Process.
D. Sterility Assurance
Physical, biological and chemical monitoring shall be routinely performed to verify the effectiveness of
sterilizers and the sterilization process.
1. Physical Monitors
A physical monitor is a device that monitors the physical conditions in a chamber during sterilization (e.g.
time, temperature and pressure). These conditions are recorded (as a printout or electronic record) on
completion of each cycle.
206
Refer to the CSAs Effective Sterilization in Health Care Facilities by the Steam Process [CSA
Z314.3-09 Clause 12.6.4] for more information about biological indicators for steam sterilizers.
Refer to the CSAs Effective Sterilization in Health Care Facilities by the Ethylene Oxide
207
Process [CSA Z314.2-09 Clause 12.6.4] for more information about biological indicators for
ethylene oxide sterilizers.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
There are six classes of chemical indicators (see Table 2, below International Classes of Steam
Chemical Indicators). When choosing a CI, ensure that the manufacturer supplies documented evidence
that the CI has been validated for use with North American cycle parameters.
Table 2: International Classes of Steam Chemical Indicators
Class
Definition
Use
Examples
CLASS I:
Process
Indicators
Process indicators
differentiate processed
from non-processed items
Sterilization
tape
Indicator labels
Load cards
Some internal
chemical
indicator strips
CLASS II:
Indicator for
Use in
Specific
Tests
Bowie-Dick test
CLASS III:
Single
Variable
Indicator
Temperature
tubes
Some internal
indicator strips
CLASS IV:
Multivariable
Indicator
Some internal
indicator strips
CLASS V:
Integrating
Indicator
Some Internal
indicator strips
CLASS VI:
Internal
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Class
Definition
Use
Emulating
Indicator
Examples
indicator strips
211
Refer to the CSAs Effective Sterilization in Health Care Facilities by the Steam Process [CSA
Z314.3-09 Clause 12.6.3] for more information about chemical indicators for steam sterilizers.
Refer to the CSAs Effective Sterilization in Health Care Facilities by the Ethylene Oxide
212
Process
[CSA Z314.2-09 Clause 12.6.3] for more information about chemical indicators for
ethylene oxide sterilizers.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Requalification of Sterilizers
Sterilizers shall be requalified annually. Refer to CSA Z314.3-09 or Z314.02-09 Section 12.4 for more
information on Requalification. Sterilizers shall also be requalified after the following events or conditions:
215, 216
i)
ii)
Major repairs;
Construction, relocation or other environmental changes to the sterilizer and/or its
services;
iii) Unexplained sterility failures;
iv) Changes in sterilant supply or delivery; and
v) Repairs or modification to the emission control system (for ethylene oxide sterilizers).
Performance Qualification
PQ is conducted by the health care facility to confirm that the installed equipment is able to sterilize the
trays and loads that are used by that facility.
For specific information on OQ and PQ requirements, refer to CSA Z314.3-09 section 12.4 and 12.5
217
The incubator
BI Controls
b) Used only for the sterilizer type and cycle for which it was designed and validated
c) Interpreted only by qualified staff
d) Used before the expiration date
e) Stored in accordance with the manufacturers instructions.
220
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
of the package. The class of indicator chosen shall be based on the parameters to be measured
and the degree of precision that is needed;
b) Each package or container to be sterilized shall have an externally visible chemical indicator.
The indicator shall be examined immediately after sterilization and immediately prior to use, to
verify that the package has been exposed to the sterilant.
223
F. New Sterilizers
Appropriate experts shall be consulted prior to the purchase of a new sterilizer (e.g. medical device
reprocessing, infection prevention and control, physical plant, biomedical engineering).
Prior to evaluation or purchase of sterilization equipment, accessories or supplies, appropriate approvals
and licenses shall be verified, e.g. DIN for chemical sterilants, CSA approval for electrical equipment.
Sterilization equipment shall be installed, operated and maintained according to the sterilizer
manufacturers instructions for use. (Refer to CSA Z314.3-09 section 12.3 Installation Qualification (IQ)
226
and Section 12.4 Operational Qualification (OQ) for further information).
Sterilizers shall be tested on installation, in routine use and following disruptions to their normal operation:
a) Following installation of a new sterilizer, the sterilizer shall pass three consecutive cycles with the
appropriate challenges (i.e., biological, chemical) in the empty sterilizer chamber as described in
227
the CSAs Effective Sterilization in Health Care Facilities by the Steam Process
[CSA Z314.309 Clause 12.4.]; In sterilizers with multiple cycles, each type of cycle shall be similarly
challenged.
b) For dynamic air removal steam sterilizers (vacuum), three consecutive air removal tests shall be
228
conducted in an empty sterilizer with an air detection test pack (e.g., Bowie-Dick) , as described
229
in the CSAs Effective Sterilization in Health Care Facilities by the Steam Process [CSA
Z314.3-09 Clauses 12.4.];
c) A sterilizer shall not be approved for use if any of the tests fail. If any test fails, the sterilizer
manufacturer shall be consulted. (Refer to CSA Z314.3-09 section 12.4.1.7 for further guidance).
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
82. The user shall obtain written functional compatibility information from the device
manufacturer and sterilizer efficacy information from the sterilizer manufacturer when using
chemical (low temperature) sterilization methods.
83. Packaging used for chemical sterilization of devices shall be validated for that method.
84. Facilities that use ethylene oxide for sterilization shall comply with the workplace health and
safety regulations as well as guidelines from Environment Canada.
85. Physical, biological and chemical monitoring shall be routinely performed to verify the
effectiveness of sterilizers and the sterilization process. (NB Chemical indicators do not
indicate that a device is sterile and do not replace the need to use a BI)
86. Sterilizers shall be requalified annually.
87. Sterilizers shall also be requalified after the following:
Major repairs;
Construction, relocation or other environmental changes to the sterilizer and/or its
services;
Unexplained sterility failures;
Changes in sterilant supply or delivery; and
Repairs or modification to the emission control system (for ethylene oxide sterilizers).
88. Appropriate experts shall be consulted prior to the purchase of a new sterilizer.
89. Sterilization equipment shall be installed, operated and maintained according to the sterilizer
manufacturers instructions for use.
90. Sterilizers shall be tested on installation, routinely following MIFUs, and following disruptions
to their normal operation.
11.
A. Storage Areas
. 231
233, 234,235
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
a) Storage containers that are moisture-resistant and cleanable (i.e., corrugated cardboard boxes
shall not be used);
b) Clean, dry, and dust-free area, that is easy to clean;
c) Storage shelving that is non-porous, smooth and cleanable (wood is not acceptable). Open
shelves shall be at least 250 mm (10 in) off the floor, 460 mm (18 in) from the ceiling and 50 mm
(2 in) from outside walls. Bottom and the top shelves shall be solid;
d) Adequate space to prevent crushing and damage of packages;
e) A system to ensure packages are rotated i.e. first in first out (FIFO); and
f) Handling, pick-up and delivery systems that prevent contamination or damage to the device.
Refer to Appendix C, Recommendations for Physical Space for Reprocessing
12.
A. Other Documentation
All documentation shall be dated and signed by the person completing the documentation and/or verifying
the test results.
Documentation of the sterilization process shall include:
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Package label:
o Name of device (when necessary);
o Initials of technician packaging the device; and
o Lot control information which includes a load/cycle number, sterilizer number, and the date of
sterilization.
Detailed list of sterilizer load contents;
Date, time and results of all tests performed (e.g. printout, CI, BI, Bowie-Dick, leak test):
o Sterilizer physical parameters shall be verified by the individual responsible for releasing the
load prior to load release. Verification shall be documented (e.g. printout is initialed);
o If any indicator fails, the failure shall be investigated. Loads may be recalled according to the
results of the investigation and the facilitys recall procedure. All actions associated with an
investigation shall be documented.
A process to address any indicator failure e.g. printout, chemical indicator or biological indicator; and
Record retention according to corporate administrative directives and/or quality management system
requirements.
B. Other Documentation
In addition to documentation of sterilization, a QA plan shall include documentation related to:
Management roles and responsibilities;
Resources;
Staff training, education and competency assessments;
Internal compliance and Reporting Systems:
o Adverse events/Incident reports.
Standards and best practices;
Reprocessing cycle management:
o Policies and standard operating procedures (SOPs);
o Test/monitoring results e.g. cleaning efficacy, BI results for sterilization; and
o Equipment maintenance.
Current MIFUs for reprocessing equipment and for medical devices being reprocessed; and
OH&S including MSDS.
C. Adverse Events
An adverse event is one that creates doubt that all required reprocessing steps were performed correctly.
Examples of reprocessing adverse events include (but are not limited to):
Incorrect reprocessing method used;
Reprocessing parameters not met;
Positive biological indicator;
Failed chemical indicator;
High level disinfection failure;
Release of a non-sterile medical device(s);
Wet sterilization load;
Incorrect AER connections used for the wrong endoscope;
Medical device alert:
o Health care settings shall have a process for receiving and disseminating medical device
237
alerts and recalls originating from manufacturers or government agencies.
| Page 63 of 136 pages
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
D. Recalls
In certain circumstances, medical devices may need to be recalled due to improper reprocessing.
238
A procedure shall be established for the recall and shall:
a. Be in writing;
b. Outline the circumstances for issuing a recall order;
c. Designate the personnel authorized to issue a recall order;
d. Outline the procedure to be followed; and
e. Designate the person responsible for reporting the result of the recall.
The recall order shall:
a. Be in writing;
b. Identify the medical device(s) to be recalled including type and quantity;
c. Identify the department(s) to which the order applies;
d. Specify the action to be taken by the person receiving the order (e.g. return, destroy); and
e. Be retained according to the health care facility policy.
Report of the recall order shall:
a) Be in writing;
b) Identify the circumstances that prompted the recall order;
c) List the medical device(s) included in the recall order;
d) List the departments or individuals notified of the recall;
e) State, in terms of the total number of medical devices intended to be recalled, the percentage
of devices actually located;
f) Include an incident report for devices that were recalled but could not be located;
g) Specify the corrective action taken to prevent a recurrence; and
h) Be retained according to the facility policy.
i)
Summary of Section 12 Recommendations
95. All reprocessing documentation shall be dated and signed by the person completing the
documentation and/or verifying the test results.
96. The sterilization process shall be documented.
97. A written procedure shall be established for recall.
98. Health care settings shall have a process for receiving and disseminating medical device
alerts and recalls originating from manufacturers or government agencies.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
13.
Health care settings shall have written policies regarding single-use medical devices. Critical and semicritical medical devices labelled as single-use shall not be reprocessed and re-used unless the
239,240,241
reprocessing is done by a licensed reprocessor.
Currently there are no licensed reprocessors in
Canada. There are reprocessors in the USA licensed by the United States Food and Drug Administration
(USFDA).
Health care settings that wish to have their single-use medical devices reprocessed by a licensed
reprocessor shall ensure that the reprocessors facilities and procedures have been certified by a
regulatory authority or an accredited quality system auditor to ensure the cleanliness, sterility, safety and
242
functionality of the reprocessed devices.
In order to have critical or semi-critical medical /devices
reprocessed by one of these facilities, there shall be quality assurance processes for:
a)
b)
c)
d)
e)
f)
g)
h)
Single-use medical
devices are usually
labelled by the
manufacturer with a
symbol:
Health care settings shall have written policies regarding single-use medical devices.
100. Critical and semi-critical medical devices labelled as single-use shall not be reprocessed
and re-used unless the reprocessing is done by a licensed reprocessor.
| Page 65 of 136 pages
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
101. In the interests of staff safety, devices that cannot be cleaned safely shall be single use.
102. Reusable devices with small lumens such as catheters, drains, and fine cannulae should be
designated single-use and not be reprocessed and reused.
103. Devices owned by the client that are re-used in their home must be adequately cleaned prior
to reuse.
104. Home health care agencies may consider re-using single-use semi-critical medical devices
for a single client in their home when reuse is safe.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Recommendations Summary of Best Practices for Cleaning, Disinfection and Sterilization of Medical
Devices in BC Health Authorities
Action Plan
Accountability
Non-compliant
Partial Compliance
Recommendation
Compliant
This summary table is intended to assist with self-assessment internal to the health care setting for quality improvement purposes. See complete text for rationale.
2.
3.
4.
Action Plan
Accountability
Non-compliant
Partial Compliance
Recommendation
Compliant
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
6.
7.
8.
9.
Action Plan
Accountability
Non-compliant
Partial Compliance
Recommendation
Compliant
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
12.
13.
14.
16.
Action Plan
Accountability
Non-compliant
Partial Compliance
Recommendation
Compliant
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
19.
20.
21.
Action Plan
Accountability
Non-compliant
Partial Compliance
Recommendation
Compliant
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
24.
25.
26.
Action Plan
Accountability
Non-compliant
Partial Compliance
Recommendation
Compliant
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
28.
29.
31.
32.
Action Plan
Accountability
Non-compliant
Recommendation
Partial Compliance
Compliant
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
34.
35.
36.
37.
38.
39.
(disposable)
cleaning
tools
is
Action Plan
Accountability
Non-compliant
Partial Compliance
Recommendation
Compliant
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
7. Factors Affecting Product Selection and Efficacy of Liquid Chemicals for Disinfection or Manual Sterilization
40.
41.
42.
43.
44.
Action Plan
Accountability
Non-compliant
Partial Compliance
Recommendation
Compliant
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
47.
48.
49.
50.
Action Plan
Accountability
Non-compliant
Recommendation
Partial Compliance
Compliant
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
52.
54.
55.
56.
immediately
Action Plan
Accountability
Non-compliant
Partial Compliance
Recommendation
Compliant
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
58.
59.
60.
61.
62.
63.
64.
Action Plan
Accountability
Non-compliant
Partial Compliance
Recommendation
Compliant
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
The water bottle and its connecting tube, used for cleaning the
endoscope lens and irrigation during the procedure, should
receive high-level disinfection or sterilization at least daily.
66.
67.
68.
70.
Action Plan
Accountability
Non-compliant
Partial Compliance
Recommendation
Compliant
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
71.
72.
73.
74.
75.
76.
77.
78.
79.
Action Plan
Accountability
Non-compliant
Partial Compliance
Recommendation
Compliant
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
83.
84.
85.
86.
87.
Action Plan
Accountability
Non-compliant
Recommendation
Partial Compliance
Compliant
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
89.
90.
92.
93.
94.
249
Action Plan
Accountability
Non-compliant
Partial Compliance
Recommendation
Compliant
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
97.
98.
101.
102.
103.
104.
Action Plan
Accountability
Non-compliant
Partial Compliance
Recommendation
Compliant
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Appendix A:
Health Canada Guidance Document: Information to be Provided by Manufacturers for the
Reprocessing and Sterilization of Reusable Medical Devices
Details of reprocessing instructions as recommended in CAN/CSA/ISO 17664
Note: This table is intended to serve as a checklist for the manufacturer and should be made available to users in addition to, or in conjunction with, the
detailed instructions for use and reprocessing. Manufacturers should indicate whether each of these processes and steps is recommended or not
recommended. Attach a copy of the validated, detailed reprocessing instructions where applicable.
Product Name:
Manufacturer:
Product Number (optional):
Contact (Name, telephone number, email address):
Specify the intended use of device and method of reprocessing required by checking the appropriate box or boxes:
Non-critical contact (contacts intact skin only); requires low level disinfection
Semi-critical contact (contacts mucosal surface but does not enter sterile body site); requires high level disinfection
Critical contact (enters sterile body site or is exposed to blood); requires sterilization
If more than one box is checked, separate forms and processes are needed.
Process
Recom'd Not
Specific information to be provided by manufacturer (attach
Recom'd details)
Specify type of detergent or agent to use for soak (for example [e.g.]
alkaline, acidic, neutral pH, enzymatic solution, enzymatic foam, or
water).
Specify maximum soak time and volume of rinse solution.
Decontamination
Preparation
Disassembly
Cleaning
(includes
rinsing)
Manual cleaning
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Ultrasonic
Cleaning
Disinfection
Thermal
Automated only
Drying
Reassembly
Maintenance
Steam sterilization
Specify time and temperature for which sterilization of device has been
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Steam sterilization
removal
validated.
Dynamic air
removal
Gravity
displacement
Specify time and temperature for which medical device has been
validated
Where possible, specify time and temperature cycles used in North
American health care facilities, i.e., 132C for 4 minutes or 135 C for 3
minutes. (See CSA Z314.3 and AAMI ST 79.) If extended cycles are
required, use 121C for 40 or 60 minutes.
ETO Sterilization
Validate that EtO residues are acceptable after standard aeration time
of 12 hours.
Other sterilization
processes
Device to be sterilized in
container provided by
manufacturer
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
MANUFACTURERS RECOMMENDATIONS FOR PRODUCT, CONCENTRATION AND EXPOSURE TIME SHALL BE FOLLOWED
Level of Reprocessing
Type of Device
Cleaning
Physical removal of soil, dust or foreign
material. Chemical, thermal or mechanical
aids may be used. Cleaning usually involves
detergents or enzymatic cleaners and water.
Thorough cleaning shall take place before
disinfection or sterilization.
Low-Level Disinfection
Level of disinfection required when
processing noncritical equipment and
devices or environmental surfaces. Lowlevel disinfectants kill most vegetative
bacteria and some fungi as well as
enveloped (lipid) viruses. Low-level
disinfectants do not kill mycobacteria or
bacterial spores.
Products**
** concentration and contact
time are dependent on
manufacturers instructions
Enzymatic cleaners
Detergents
0.5% Accelerated hydrogen
peroxide
Environmental surfaces touched by staff
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
MANUFACTURERS RECOMMENDATIONS FOR PRODUCT, CONCENTRATION AND EXPOSURE TIME SHALL BE FOLLOWED
Level of Reprocessing
Type of Device
Products**
client/patient/resident use
High-Level Disinfection
The level of disinfection required when
processing semi-critical devices.
Semi-critical devices
Sterilization
The level of reprocessing required when
processing critical device.
Sterilization results in the destruction of all
forms of microbial life including bacteria,
viruses, spores and fungi.
Critical devices
cavities or tissues
TEE probes
Laryngoscopes
Flexible bronchoscopes and flexible
cystoscopes (sterilization is preferred)
Respiratory therapy equipment
Nebulizer cups
Anaesthesia equipment
Specula (nasal, anal, vaginal disposable
equipment is strongly recommended)
Tonometer foot plate
Ear syringe nozzles
Sonography (ultrasound) endocavity probes
(e.g. transrectal, vaginal probes)
Pessary and diaphragm fitting rings
(sterilization is preferred)
Cervical caps
Glass thermometers
CPR face masks
Ear cleaning equipment e.g. ear curettes,
otoscope tips
Surgical instruments
Implantable devices
Rigid endoscopes that enter sterile cavities
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
MANUFACTURERS RECOMMENDATIONS FOR PRODUCT, CONCENTRATION AND EXPOSURE TIME SHALL BE FOLLOWED
Level of Reprocessing
Type of Device
Products**
Colposcopy equipment
Electrocautery tips (single use is preferred)
Endocervical curettes
Eye equipment
Dental equipment including high speed dental
hand pieces
Nail and foot care equipment used on more
Adapted from:
Health Canadas Hand Washing, Cleaning, Disinfection and Sterilization in Health Care [available at: http://www.phac-aspc.gc.ca/publicat/ccdrrmtc/98pdf/cdr24s8e.pdf.
Center for Disease Control and Preventions Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 [available at:
http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_Nov_2008.pdf]
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
A. Space
3. There shall be adequate space provided for decontamination equipment and products used for cleaning and reprocessing :
a) Work surfaces and surrounding areas should be designed to minimize crowding of work space;
b) Work surfaces shall be flat, cut-resistant, seamless and composed of a non-porous material so they can be cleaned, disinfected and dried.
Stainless steel surfaces and backsplashes are recommended;
c) There should be at least two adjacent decontamination sinks. If only one sink is available, precautions should be taken to avoid re-contaminating
devices. Decontamination sinks should:
i)
Be at a height that allows staff to use them without bending or straining;
ii)
Be deep enough to completely immerse items to be cleaned ;
iii)
Be large enough to accommodate trays or baskets of instruments;
iv)
Not have an overflow; and
v)
Should be equipped with water ports for the flushing of instruments with lumens.
4. There should be an area for donning or removing Personal Protective Equipment (PPE):
PPE shall be carefully removed and hands thoroughly washed before moving from dirty to clean area.
| Page 90 of 136 pages
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
252
1.
254, 255
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
vii)
viii)
For more information about Hospital Clean, see the MOHLTCs Best Practices for Environmental Cleaning in All Health Care Settings.
256
257,
In healthcare facilities ventilation, temperature and humidity of the Medical Device Reprocessing Department shall meet CSA standards
258
:
a) CSA requirements for ventilation:
i)
Minimum 10 air changes per hour for soiled and clean areas. Minimum 2 outdoor air changes per hour for soiled areas, 3 outdoor air
changes per hour for clean areas;
ii)
Soiled areas: negative pressure;
iii)
Clean areas: positive pressure;
iv)
Exhaust air vented outdoors and not recirculated; and
v)
Portable fans should not be used in any reprocessing area.
References
1. American Institutes of Architects. Guidelines for Design and Construction of Health Care Facilities. The American Institute of Architect: 2006.
2. American National Standards Institute. Emergency Eyewash and Shower Equipment. ANSI/ISEA Z358.1: 2009.
3. Association for the Advancement of Medical Instrumentation. ANSI/AAMI TIR34/ED.2 & TIR34. Water for the Reprocessing of Medical Devices.
Arlington, VA: Association for the Advancement of Medical Instrumentation: 2008.
4. Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST55. Table Top Steam Sterilizers. Arlington, VA: Association for the
Advancement of Medical Instrumentation: 2010.
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5. Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST58. Chemical Sterilization and High Level Disinfection in Health Care
Facilities. Arlington, VA: Association for the Advancement of Medical Instrumentation: 2005.
6. Barry C., Boyd N., Cleator N., et al. Infection Prevention and Control: Best Practices for Long Term Care, Home and Community Care Including
Health Care Offices and Ambulatory Clinics. Canadian Committee on Antibiotic Resistance; 2007 Jun [cited 2011 June 20]. Available from:
http://www.phac-aspc.gc.ca/amr-ram/ipcbp-pepci/pdf/amr-ram-eng.pdf
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http://www.health.gov.bc.ca/library/publications/year/2011/Best-practice-guidelines-cleaning.doc
9. British Columbia Ministry of Health. Best Practices for the Cleaning, Disinfection and Sterilization of Medical Devices in Health Authorities. 2007.
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10. British
Columbia
Ministry
of
Health.
Policy
Communiqu:
Reprocessing
of
Medical
Devices.
2011.
Available
from:
http://www.health.gov.bc.ca/library/publications/year/2011/Reprocessing-policy-communique.doc
11. British Columbia Ministry of Healthy Living and Sport. Public Health Act, RSBC 2008; [cited September 21, 2010]; Available from:
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12. British Columbia. Ministry of Health. Home and Community Care Policy Manual. Available from; http://www.health.gov.bc.ca/hcc/policy.html.
13. British Columbia. WorkSafeBC. Occupational Health and Safety Guidelines, part 5: Chemical Agents and Biological Agents- Controlling Exposure,
RSBC 1996, and Occupational Health and Safety Regulations. Available from:
http://www2.worksafebc.com/Publications/OHSRegulation/GuidelinePart5.asp#EL_Table
14. British Columbia. WorkSafeBC. Workers Compensation Act, RSBC 1996, and Occupational Health and Safety Regulations. Available from:
http://www2.worksafebc.com/Publications/OHSRegulation/Home.asp.
15. Canadian Healthcare Association. The Reuse of Single-Use Medical Devices: Guidelines for Healthcare Facilities. Ottawa: CHA Press; 1996.
16. Canadian Standards Association. CAN/CSA Z314.15.10, Section 8: Warehousing, Storage and Transportation of Clean and Sterile Medical Devices.
Rexdale: Ont.: Canadian Standards Association: 2010.
17. Canadian Standards Association. CAN/CSA Z314.22-10 Management of Loaned, Reusable Medical Devices. Rexdale, Ont.: Canadian Standards
Association: 2010.
18. Canadian Standards Association. CAN/CSA Z314.8-08 Decontamination of Reusable Medical Devices. Mississauga, Ont.: Canadian Standards
Association: 2008.
19. Canadian Standards Association. CAN/CSA Z317.13-07 Infection Control during Construction, Renovation and Maintenance of Health Care Facilities.
Mississauga, Ont.: Canadian Standards Association; 2007.
20. Canadian Standards Association. CAN/CSA Z317.2-01 (R2008) Special Requirements for Heating, Ventilation, and Air Conditioning (HVAC) Systems in
Health Care Facilities. Toronto: Canadian Standards Association; 2001.
21. Canadian Standards Association. CAN/CSA-Z11140-1-07 Sterilization of Health Care Products - Chemical Indicators - Part 1: General Requirements.
Canadian Standards Association: 2007.
22. Canadian Standards Association. CAN/CSA-Z15882-04 Sterilization of Health Care Products: Chemical Indicators - Guidance for Selection, Use and
Interpretation of Results. Mississauga, Ont.: Canadian Standards Association: 2004.
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23. Canadian Standards Association. CAN/CSA-Z314.2-09 Effective Sterilization in Health Care Facilities by the Ethylene Oxide Process. Rexdale, Ont.:
Canadian Standards Association: 2009.
24. Canadian Standards Association. CAN/CSA-Z314.3-09 Effective Sterilization in Health Care Facilities by the Steam Process. Rexdale, Ont.: Canadian
Standards Association: 2009.
nd
25. Canadian Standards Association. PLUS 1112. Infection Prevention and Control in Office-Based Health Care and Allied Services (2 edition).
Rexdale, Ont.: Canadian Standards Association: 2004.
26. Department of Justice Canada. Food and Drugs Act. Medical Devices Regulations, SOR/98-282; 1998 June 2, 2009. Available from:
http://laws.justice.gc.ca/en/f-27/sor-98-282/text.html. http://laws.justice.gc.ca/eng/regulations/SOR-98-282/
27. Environment Canada. Guidelines for the Reduction of Ethylene Oxide Releases from Sterilization Applications. October 1, 2005. Available from:
http://www.ec.gc.ca/CEPARegistry/guidelines/ethylene_oxide.cfm.
28. Hamasuna R, Nose K, Osada Y, Muscarella LF. Correction: high-level disinfection of cystoscopic equipment with ortho-phthalaldehyde solution [letter].
Journal of Hospital Infection 2005; 61(4):363-4.
29. Health Canada. Classic Creutzfeldt - Jakob disease in Canada. An Infection Control Guideline. Can Commun Dis Rep 2002; 28 Suppl 5:1-84.
30. Health Canada. Infection Control Guidelines: Hand Washing, Cleaning, Disinfection and Sterilization in Health Care [currently under revision]. Can
Commun Dis Rep 1998: 24 Suppl 8:1-55.
31. Health Canada. Infection Control Guidelines: Routine Practices and Additional Precautions for Preventing the Transmission of Infection in Health Care
[under revision]. Can Commun Dis Rep 1999; 25 Suppl 4: 1 142.
32. Health Canada. Therapeutic Products Directorate. Reprocessing of Reusable and Single-Use Medical Devices. [Letter to hospital administrators, July
30, 2004]. Available from: http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/announce-annonce/reprocess_retraitement_let-eng.php.
33. International Organization for Standardization (ISO) 11138-1-06. Sterilization of health care products - Biological indicators - Part 1: General
requirements. First ed. Geneva, Switzerland: 2006.
34. International Organization for Standardization (ISO) 17664. Medical Device Manufacturers: Information to be provided by the Manufacturer for the
Reprocessing of Resterilizable Medical Devices. Geneva, Switzerland: 2004.
35. Kohn WG, Collins AS, Cleveland JL, Harte JA, Eklund KJ, Malvitz DM. Guidelines for Infection Control in Dental Health-Care Settings. MMWR Recomm
Rep 2003: 52(RR-17):1-61.
36. Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes. Gastrointest Endosc 2003: 58(1):1-8.
37. Ontario Hospital Association & Ontario Medical Association Joint Committee on Communicable Diseases Surveillance Protocols. Blood Borne Diseases
Surveillance Protocol for Ontario Hospitals; 2008. Available from:
http://www.oha.com/Services/HealthSafety/Documents/Protocols/Blood%20Borne%20Diseases%20Protocol%20%20Reviewed%20and%20Revised%20November%202010.pdf
38. Ontario Hospital Association. Reuse of Single-Use Medical Devices Ad-hoc Working Group. [Toronto, Ontario]: [Ontario Hospital Association]; 2004.
Available from: http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/sci-consult/reproc-retraite/saprmd_rop_gcsrmm_crd_2005-02-10-eng.php
39. Ontario. Ministry of Health and Long-Term Care. Provincial Infectious Diseases Advisory Committee. Routine Practices and Additional Precautions in All
Health Care Settings, 2009. Available from: http://www.health.gov.on.ca/english/providers/program/infectious/diseases/ic_routine.html.
40. Ontario. Occupational Health and Safety Act and WHMIS regulation: Revised Statutes of Ontario, 1990, chapter O.1, Reg. 860 Amended to O. Reg.
36/93 Toronto, Ontario: Ontario Ministry of Labour Operations Division; 2001. Report No.: 0779405617.
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41. Ontario. Occupational Health and Safety Act, R.S.O. 1990, c.O.1; Designated Substance - Ethylene Oxide, R.R.O. 1990, Reg. 840, Amended to O. Reg.
107/04. Available from: http://www.e-laws.gov.on.ca/html/regs/english/elaws_regs_090490_e.htm#BK24
42. Ontario. Occupational Health and Safety Act, R.S.O. 1990, cO.1: Control of Exposure to Biological or Chemical Agents, R.R.O. 1990, Regulation 833
Amended to O.Reg. 607/05. [Part 5: Ceiling Exposure Values (CEV) for Biological and Chemical Agents]. Available from: http://www.elaws.gov.on.ca/html/source/regs/english/2005/elaws_src_regs_r05607_e.htm.
43. Ontario. Occupational Health and Safety Act. Ontario Regulation 474/07. Needle Safety; 2007. Available from: http://www.elaws.gov.on.ca/Download?dDocName=elaws_regs_070474_e.
44. Ontario. Ontario. Occupational Health and Safety Act, R.S.O. 1990, c.O.1: Control of Exposure to Biological or Chemical Agents, R.R.O. 1990,
Regulation 833 Amended to O. Reg. 607/05. [Part 5: Ceiling Exposure Values (CEV) for Biological and Chemical Agents]. Available from: http://www.elaws.gov.on.ca/html/source/regs/english/2005/elaws_src_regs_r05607_e.htm.
45. Provincial Infection Control Network (PICNet). Hand Hygiene Resource Page [cited September 21, 2010]; Available from:
http://www.picnetbc.ca/hand_hygiene.htm#Standards
46. Public Health Agency of Canada. Handwashing, Cleaning, Disinfection and Sterilization in Health Care'. Released 1998. [cited September 21, 2010];
Available from: http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/98pdf/cdr24s8e.pdf.
47. Public Health Agency of Canada. Infection Prevention and Control Guideline for Flexible Gastrointestinal Endoscopy and Flexible Bronchoscopy,
2010. Available from: http://phac-aspc.gc.ca/nois-sinp/guide/endo/pdf/endo-eng.pdf.
48. Riley R, Beanland C, Bos H. Establishing the Shelf Life of Flexible Colonoscopes. Gastroenterol Nurs 2002: 25(3):114-9.
49. Rutala WA, Gergen MF, Weber DJ. Evaluation of a Rapid Readout Biological Indicator for Flash Sterilization with Three Biological Indicators and Three
Chemical Indicators. Infect Control Hosp Epidemiol 1993; 14(7):390-4.
50. Rutala WA, Jones SM, Weber DJ. Comparison of a Rapid Readout Biological Indicator for Steam Sterilization with Four Conventional Biological
Indicators and Five Chemical Indicators. Infect Control Hosp Epidemiology 1996; 17(7):423-8.
51. Rutala WA, Weber DJ. Guideline for Disinfection and Sterilization of Prion-Contaminated Medical Instruments. Infect Control Hosp Epidemiol 2010;
31(2):107-17.
52. Rutala WA, Weber DJ. Healthcare Infection Control Practices Advisory Committee (HICPAC). Guideline for Disinfection and Sterilization in Healthcare
Facilities, 2008; 2008. Available from: http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_Nov_2008.pdf.
53. Spaulding E. The Role of Chemical Disinfection in the Prevention of Nosocomial Infections. In: International Conference on Nosocomial Infections; 1970
1971; Chicago, IL: American Hospital Association; 1970. p. 254-74.
54. The College of Physicians and Surgeons of BC. Infection Prevention and Control (IPAC) in Physicians Offices, Resource Manual. Available from:
https://www.cpsbc.ca/files/u6/Infection-Prevention-and-Control-in-Physician-Offices.pdf
55. The Community Care and Assisted Living Act, available at:http://www.bclaws.ca/EPLibraries/bclaws_new/document/ID/freeside/00_02075_01
56. The Continuing Care Act, RSBC 1996, available at: http://www.bclaws.ca/EPLibraries/bclaws_new/document/ID/freeside/00_96070_01
57. The Hospital Act Regulation, 2008, available at: http://www.bclaws.ca/EPLibraries/bclaws_new/document/ID/freeside/10_121_97
58. The Hospital Insurance Act, RSBC 1996, available at: http://www.bclaws.ca/EPLibraries/bclaws_new/document/ID/freeside/00_96204_01
59. The Residential Care Regulation, RSBC 2009, Regulation , available at:http://www.bclaws.ca/EPLibraries/bclaws_new/document/ID/freeside/96_2009
60. Transport Canada. Transportation of Dangerous Goods Act, 1992; 1994. Available from: http://laws.justice.gc.ca/en/T-19.01/.
61. Whyman CA, McDonald SA, Zoutman D. Unsuspected Dilution of Glutaraldehyde in an Automatic Washer for Flexible Fibreoptic Endoscopes. Can J
Infect Control 1991; 6(4):91-3.
| Page 95 of 136 pages
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
2.
Water used in the processing area should be tested and be free of contaminants:
Water quality can be a significant factor in the success of decontamination procedures. In addition to issues of mineral content (hardness or softness),
piped water supplies can also introduce pathogens and unwanted chemicals to decontamination processes. Manufacturers of medical device,
decontamination equipment, and detergents should be consulted regarding their particular water quality requirements.
For further information on water quality refer to:
o Annex F in the Canadian Standards Associations Decontamination of Reusable Medical Devices CAN/CSA-Z314.8-08
o AMMI TIR 34 (2007), Water for the reprocessing of medical devices.
Adapted from:
Canadian Standards Association. Decontamination of Reusable Medical Devices. CAN/CSA-Z314.8-08. 2008.
Canadian Standards Association. Effective Sterilization in Health Care Facilities by the Steam Process. CAN/CSA-Z314.3-09. 2009
Canadian Standards Association. Special Requirements for Heating, Ventilation, and Air Conditioning (HVAC) Systems in Health Care Facilities. February
2003.
The American Institute of Architects Academy of Architecture for Health. Guidelines for Design and Construction of Hospital and Health Care Facilities.
2006 edition.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Appendix D:
Advantages and Disadvantages of Currently Available
Sterilization and High Level Disinfection Options
STERILIZATION
MANUFACTURERS RECOMMENDATIONS FOR PRODUCT CONCENTRATION AND EXPOSURE TIME SHALL BE FOLLOWED
PROCESS OPTION
COMMENTS
STERILIZATION
Dry Heat
Gravity convection
Indications:
For critical devices that will be damaged by moisture, pressure and/or vacuum
Mechanical convection
Ref: ISO 20857
Monitoring
Sterilization shall be monitored with biological indicators (at least daily), chemical indicators (each package) and
physical indicators (each cycle)
Advantages
Non-corrosive
Reaches internal parts that cannot be disassembled for direct sterilant contact (via heat conduction)
Inexpensive
Disadvantages
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
PROCESS OPTION
COMMENTS
STERILIZATION
Ethylene Oxide (EtO) gas
Indications:
For critical devices and some semi-critical devices that will be damaged by moisture and /or heat
Monitoring
Sterilization shall be monitored with biological indicators (each load), chemical indicators (each package)
and physical indicators (each cycle)
Advantages
Non-corrosive
Disadvantages
Indications:
For emergency sterilization of critical devices that are heat and moisture tolerant
Shall not be used for implantable devices or for complete sets or trays of instruments
Any trays or wrappers that are used for Flash sterilization must be validated for that purpose.
Monitoring
Sterilization shall be monitored with biological indicators (at least daily), chemical indicators (each package) and
physical indicators (each cycle)
BI testing shall include each type of cycle and load configuration (e.g., open tray, enclosed container, single
wrapper) to be used that day.
Cycles shall be documented in such a way that the flashed device can be linked to the patient on which it was
used should there be an adverse sterilization event e.g. failed BI
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
PROCESS OPTION
COMMENTS
STERILIZATION
Advantages
Fast
Disadvantages
Glutaraldehyde (GTA)
(2.4%-3.5%)
Devices cannot be stored because they are still wet on cycle completion
Requirement to follow all of the steps of safe sterilization practice (e.g. decontamination, sterilizer monitoring and
maintenance, aseptic transfer to the sterile field) may be onerous or impossible to achieve in some settings.
For immersible, heat sensitive critical devices and some semi-critical devices
Monitoring
Test strips to confirm the minimal effective concentration (MEC) of the solution should be used each time the
solution is used.
There are no biological indicators or chemical indicators to monitor GTA exposure conditions and demonstrate
microbial kill
Disadvantages
In-use life may be limited (e.g. 14 days, 28 days). Refer to manufacturers instructions for use
The use of glutaraldehyde as a sterilant is strongly discouraged for the following reasons:
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
PROCESS OPTION
COMMENTS
STERILIZATION
Hydrogen PeroxideAccelerated (7% and 2 %)
For immersible, heat sensitive critical devices and some semi-critical devices that will be damaged by the
various sterilization methods
SciCan Optim CS 7%
Accel CS 20 7%
Steris Resert 2%
Monitoring
Minimal effective concentration (MEC) of solution shall be monitored at least daily, and more often if the solution
is heavily used.
There are no biological indicators or chemical indicators to monitor hydrogen peroxide exposure conditions
Advantages
Disadvantages
In-use life is limited to 21 days or failure of the MEC test, whichever comes first. Refer to product manufacturers
instructions for use
Strong oxidizer. Depending on the concentration, it can be corrosive to some materials e.g. copper, brass,
carbon-tipped devices and aluminium
May cause irritation and chemical burns to eyes or to mouth and throat if swallowed. May cause slight irritation
to skin
The use of hydrogen peroxide as a sterilant is strongly discouraged for the following reasons:
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
PROCESS OPTION
COMMENTS
STERILIZATION
Hydrogen peroxide vapour
and gas (may also include
plasma)
Sterradby Advanced
Sterilization Products
Indications:
For critical devices and some semi-critical devices that will be damaged by moisture or heat
Monitoring
Sterilization shall be monitored with biological indicators (at least daily), chemical indicators (each package)
and physical indicators (each cycle)
V Proby Steris
Advantages
HMTSby SciCan
Fast compared to ETO. Some cycles are faster than steam sterilization
Disadvantages
May be incompatible with some devices. Compatibility must be confirmed with both sterilizer and device
manufacturers
Cannot sterilize materials which absorb hydrogen peroxide (e.g. linen, gauze, cellulose/paper, wood)
Wraps and trays must be validated for hydrogen peroxide sterilization (e.g. polypropylene wrappers, Tyvek
backed peel pouches).
Ozone
Indications:
For critical devices and some semi-critical devices that will be damaged by moisture or heat
TSO3
Monitoring
Sterilization shall be monitored with biological indicators (at least daily), chemical indicators (each package) and
physical indicators (each cycle)
Advantages
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
PROCESS OPTION
COMMENTS
STERILIZATION
Disadvantages
May be incompatible with some devices. Compatibility must be confirmed with both sterilizer and device
manufacturers
Wraps and trays must be validated Ozone sterilization (e.g. polypropylene wrappers, Tyvek backed peel
pouches).
Indications:
NB. This chemical is used only in a proprietary, controlled system
For immersible, heat sensitive critical and semi-critical devices e.g. rigid and flexible endoscopes
Monitoring
Sterilization shall be monitored with biological indicators (each day that the unit is used) , chemical indicators
(each cycle) and physical indicators (each cycle).
Manufacturers instructions for use also require that a daily Diagnostic cycle be run at the beginning of the day
before any devices are processed.
Cycles shall be documented in such a way that the device can be linked to the patient on which it was used
should there be an adverse sterilization event e.g. failed BI
Advantages
Fast
Disadvantages
Devices must be used immediately. They cannot be stored because they are still wet on cycle completion
Time and temperature are controlled by the unit and may vary due to water pressure, incoming water
temperature, or filter status).
Spore strips used for monitoring are not self contained and therefore have the potential for external
contamination.
Steam
Indications:
Pre-vacuum sterilizers
Gravity displacement
For critical devices and some semi-critical devices that will not be damaged by moisture or heat
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
PROCESS OPTION
COMMENTS
STERILIZATION
sterilizers
Small table top sterilizers
Monitoring
Sterilization shall be monitored with biological indicators (at least daily), chemical indicators (each package) and
physical indicators (each cycle)
All loads containing an implantable device shall be monitored with an additional BI and should be quarantined
until the results of that biological indicator testing are available.
Additional monitoring of Pre-vacuum sterilizers shall include a dynamic air removal test (daily)
Advantages
Inexpensive
Fast
Non-toxic
Readily available
Disadvantages
Unsuitable for anhydrous materials (e.g. oils, powders) wood, and for heat and moisture sensitive materials
Some tabletop sterilizers lack a drying cycle and /or printers (for physical monitoring of each cycle)
Safe use of steam sterilizers requires a sound knowledge of their requirements. Not all settings have this
expertise.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
HIGH-LEVEL DISINFECTION
MANUFACTURERS RECOMMENDATIONS FOR PRODUCT CONCENTRATION AND EXPOSURE TIME SHALL BE FOLLOWED
PROCESS OPTION
COMMENTS
Indications:
For immersible ,semi- critical devices that will be damaged by the various sterilization methods e.g. flexible GI
endoscopes
Monitoring
Minimal effective concentration (MEC) of reusable solutions shall be monitored at least daily, and more often if the
solution is heavily used.
Advantages
Non-corrosive
Inexpensive
Disadvantages
Reusable solutions have a limited in-use life i.e. 14-30 days depending on formulation, or failure of the MEC test,
whichever comes first. Refer to product manufacturers instructions for use.
Requires copious rinsing with sub-micron filtered water to maintain disinfection level
During reuse, the concentration drops as dilution of the product occurs. In-use life shortens when solution is
diluted
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
PROCESS OPTION
COMMENTS
Indications:
For immersible ,semi- critical devices that will be damaged by the various sterilization methods
In the US, the Society for Gastroenterology Nurses and Associates (SGNA) indicates that while 7.5% hydrogen
peroxide is approved for use as a high level disinfectant, it is not compatible with endoscopes made by
Olympus, Pentax or Fujinon.
Monitoring
Minimal effective concentration (MEC) of reusable solutions shall be monitored at least daily, and more often if the
solution is heavily used.
Advantages
Relatively inexpensive
Rapid action
Safe for the environment. Breaks down into water and oxygen
Disadvantages
Accelerated Hydrogen
Peroxide (7%)
Product examples include:
SciCan Optim CS 7%
Accel CS 20 7%
Reusable solutions have a limited in-use life. (14 days, or failure of the MEC test, whichever comes first). Refer
to product manufacturers instructions for use.
Strong oxidant can be corrosive to some materials e.g. copper, brass, carbon-tipped devices and aluminium
Requires copious rinsing with sub-micron filtered water to maintain disinfection level
Indications:
For immersible ,semi- critical devices that will be damaged by the various sterilization methods
Monitoring
Minimal effective concentration (MEC) of reusable solutions shall be monitored at least daily, and more often if the
solution is heavily used.
Advantages
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
PROCESS OPTION
COMMENTS
Relatively inexpensive
Rapid action
Safe for the environment. Breaks down into water and oxygen
Disadvantages
Reusable solutions have a limited in-use life. (14 days, or failure of the MEC test, whichever comes first). Refer
to product manufacturers instructions for use.
Accelerated Hydrogen
Peroxide (2%)
Product examples include:
Steris Resert 2%
Strong oxidant can be corrosive to some materials e.g. copper, brass, carbon-tipped devices and aluminium
May cause irritation and chemical burns to eyes or to mouth and throat if swallowed. May case slight irritation to
skin
Requires copious rinsing with sub-micron filtered water to maintain disinfection level
Indications:
For immersible ,semi- critical devices that will be damaged by the various sterilization methods
Monitoring
Minimal effective concentration (MEC) of reusable solution shall be monitored at least daily, and more often if the
solution is heavily used.
Advantages
Relatively inexpensive
Rapid action
Safe for the environment. Breaks down into water and oxygen
Disadvantages
Reusable solutions have a limited in-use life. (21 days, or failure of the MEC test, whichever comes first). Refer
to product manufacturers instructions for use.
Strong oxidant can be corrosive to some materials e.g. copper alloys, iron and other heavy metals
Requires copious rinsing with sub-micron filtered water to maintain disinfection level
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
PROCESS OPTION
COMMENTS
Indications:
For immersible ,semi- critical devices that will be damaged by the various sterilization methods e.g. flexible GI
endoscopes
Advantages
Non-corrosive
Disadvantages
Thermal disinfection
(e.g. Pasteurization)
. Refer to manufacturers
instructions for use for time and
temperature required to achieve
thermal disinfection
Examples of times at
temperatures include:
Contraindicated for urology instruments to be used on patients with a history of bladder cancer.259
Indications:
Achieves the equivalent of high-level disinfection using hot water in a proprietary, controlled system
For immersible ,semi- critical devices that will be damaged by the various sterilization methods e.g. respiratory therapy
or anaesthesia devices
Monitoring
Advantages
Physical monitoring of exposure time and temperature documented via printed and/or electronic record
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
PROCESS OPTION
COMMENTS
Disadvantages
Regular, manual verification of the thermometer and timing mechanisms of a pasteurizer are required
The following chemicals are intermediate and low level disinfectants and as such are not covered by this table:
Alcohol (60-95%)
Hypochlorites e.g. bleach,
Accelerated hydrogen peroxide (0.5%)
Hydrogen peroxide (3%)
Iodophors
Phenolics
Quaternary ammonium chlorides (QUATs)
Table information is adapted from:
Health Canadas Hand Washing, Cleaning, Disinfection and Sterilization in Health Care [currently under revision] [available at: http://www.phacaspc.gc.ca/publicat/ccdr-rmtc/98pdf/cdr24s8e.pdf.
Center for Disease Control and Preventions Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 [available at:
http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_Nov_2008.pdf]
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Appendix E:
Cross-Reference Table Accreditation Canadas Reprocessing and Sterilization of Reusable Medical
Devices and British Columbias Best Practice Guidelines for Cleaning, Disinfection and Sterilization of
Critical and Semi-critical Medical Devices
ACCREDITATION STANDARDS
BC BEST
PRACTICES
Sectio
Page #
n
RECOMMENDATION
NUMBER
1.0
The organization designs its reprocessing services to meet the needs of the
organization and partner organizations.
20-25
N/A
1.1
The organization collects information at least annually about service volumes and
patterns of medical device use
3
9H
28-29
48
15, 68
1.2
The organization reviews its operational plan and the information it collects about
service volumes and equipment use to decide which sterilization and reprocessing
services are offered within the organization.
The team works with others in the organization to limit the use of flash
sterilization to emergencies only, and never for complete sets or implantable
devices.
The organization designates a trained and competent individual with the
accountability for coordinating all reprocessing and sterilization activities
across the organization, including those performed outside the reprocessing unit or
area.
The designated person reports directly to the organizations senior
management or the executive office.
The organization has the right number and mix of staff to carry out its
reprocessing and sterilization activities.
1A
3
22-23
28-29
1, 2, 15, 16
10B vii
53
76, 77, 78
GP*
4
20-21
29-30
18
GP
20-21
18
29-30
18-22
1.3
1.4
1.5
1.6
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
ACCREDITATION STANDARDS
1.7
BC BEST
PRACTICES
Sectio
Page #
n
RECOMMENDATION
NUMBER
GP
3
20-21
29
18-22
GP
3
GP
20-21
29
20-21
18-22
29-30
18-22
2.1
The organization orients all staff members about safe work practices, including
patient safety, occupational health and safety, and infection prevention and control.
The sterilization team receives training about how to reprocess reusable
medical devices when they are first employed and whenever there is a change in
the sterilization process.
The teams training includes how to reprocess new devices and equipment used in
the organization.
29
31
29-30
39
18-29
2.2
4
5
4
7B (b)
1A
4
7B
4
23
29-30
39
30
6, 19-22
29-30
44
29
62-63
22
53
17, 53
98
29-30
48
22
53
1.8
1.9
2.0
2.3
2.4
2.5
2.6
The organization provides follow-up education, training, and supervision for staff
who have been involved in critical incidents or adverse events.
4
9A
3
12B+C
2.7
4
9H
N/A
19-22
19, 20
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
ACCREDITATION STANDARDS
3.0
The physical layout of the sterilization unit or area allows for high quality
reprocessing and the smooth flow of reusable medical devices and
equipment.
3.1
When planning and designing the layout of the sterilization unit or area, the
organization considers the volume and types of reprocessing and sterilization
services, flow of devices and equipment, and traffic patterns.
The sterilization unit or area limits access to the overall unit or area to unit or area
staff members, and posts clear signage limiting access at all entry points.
3.2
3.3
3.4
3.5
3.6
3.7
4.0
4.1
The organization sets and follows policies that address the management of the unit
or area, the team, all aspects of the sterilization process, safety, infection control,
BC BEST
PRACTICES
Sectio
Page #
n
RECOMMENDATION
NUMBER
12B
2
9B
Appx C
2A
9B
62
26-28
44-45
89-91
26
44-45
2A
9B
2A
9B
26
44-45
26
44-45
10-14
2A
9B
26
44-45
11
2B
9B
2A
9B
27
44-45
26
44
12, 55
2D
28
14
3
7A
10A+B
28-29
37
49-50
15, 16, 17
40-45
72-73
3
10A
28-29
49-50
11
10-14
10-14
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
ACCREDITATION STANDARDS
BC BEST
PRACTICES
Sectio
Page #
n
RECOMMENDATION
NUMBER
4.3
4.4
4.5
The team writes its SOPs in a clear, concise, and consistent way.
The team maintains up-to-date manufacturers information, instructions, and
recommendations for each medical device.
4.6
The team documents and maintains policies, SOPs, standards of practice, and
manufacturers instructions in a manual.
4.7
4.8
The team trains staff prior to implementing a new or amended policy, SOP, practice
standard, or manufacturers instruction.
4.9
Team leaders review and update the policies and procedures on a regular
basis and in response to critical incidents or adverse events; changes in laws,
regulations, or standards; results of internal or external audits; and new evidencebased information.
The team tracks changes to policies, SOPs, standards of practice, and
manufacturers instructions using a document control procedure.
New and changed SOPs are approved in writing by the team leaders.
4.10
4.11
5.0
28
15, 16
3
10B
12B
3
1B
7
10A
28
50-59
62
28
23-25
37-40
49-50
15-17
72,73
95-98
1B
7A
3
4
7A
3
4
3
25
37
28
30
37
28-29
29-30
28-29
4
45
15-17
40
28-29
16
28-29
15,16
5
9B
30-33
44-45
23-29, 53
45
1-9
73
15, 16, 17
18-22
15, 16, 17
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
ACCREDITATION STANDARDS
BC BEST
PRACTICES
Sectio
Page #
n
RECOMMENDATION
NUMBER
unit or area.
5.1
The reprocessing area is equipped with hand hygiene facilities at entrances to and
exits from the reprocessing units or areas, including support areas.
5.2
The unit or areas hand hygiene facilities are equipped with faucets supplied with
foot-, wrist-, or knee-operated handles, or electric eye controls.
5.3
5.4
Staff members have access to the supplies needed to support proper hand
hygiene, including properly supplied and functioning soap and towel
dispensers or waterless, alcohol-based hand rubs in the working environment.
Staff members apply proper hand hygiene technique before beginning and after
completing work activities, as well as at other key points to prevent infection.
The team follows policies that prohibit eating and drinking, food storage,
smoking, the application of cosmetics, and the handling of contact lenses in the
reprocessing unit or area.
The team follows a detailed dress code while in the clean reprocessing unit or area
that addresses clothing, hair, jewellery, artificial fingernails of any form, and
covered footwear.
The team wears the appropriate and properly maintained personal protective
equipment (PPE) when in the decontamination work areas.
The team regularly conducts workplace assessments of its sterilization and
reprocessing units or areas for ergonomics and occupational health and safety
(OHS).
The team keeps up-to-date and accessible documentation and records of its
sterilization processes.
5.5
5.6
5.7
5.8
5.9
6.0
6.1
The team maintains a complete record of each sterilization cycle, including the load
control label, recording chart or printout, process-recording record, and sterility
2A
5A
9B
5A
9B
4
5A
27
31
44-45
31
44-45
29-30
31
23
N/A
N/A
N/A
5A
31
23
5A
31
24
5A
31
23, 25
5A+B
31-32
25
30-31
29
3
10E
12
10E
12A
28-29
57-58
62-64
57-58
62
23
18, 22,
23
95, 96
| Page 113 of 136 pages
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
ACCREDITATION STANDARDS
BC BEST
PRACTICES
Sectio
Page #
n
RECOMMENDATION
NUMBER
record.
6.2
6.3
6.4
7.0
7.1
7.2
The record includes details of the sterilization cycle, including date and time;
exposure time; temperature; pressure; sterility test results; and the kind, quantity,
and origin of the devices sterilized.
The record allows team members to track individual items or devices
associated with a sterilizer or sterilization cycle.
The organization stores and retains its sterilization records according to its policies,
and any applicable laws and regulations.
The organization selects, installs, and maintains reprocessing equipment so
that it is safe to use and functions according to manufacturers
specifications.
The organization follows a process to select and purchase equipment based on
reprocessing and sterilization requirements, input from staff and service providers,
and considerations for maintenance, cleaning, and infection control.
The organization has a documented preventive maintenance and cleaning program
for its decontamination and sterilization equipment.
7.3
7.4
7.5
10B
12A
50
62
74
95, 96
1D
12A
12A
25
62
62
9
97, 98
1
10A+B
10F
13
1
10F
22-25
49-50
58-59
64-65
22-23
58-59
1, 2, 3,
73,
88, 89
3
9H
10A+B
3
9H
10A+B
12B
10A
10F
28-29
48
49-50
28-29
48
49-50
62-63
49-50
58-59
15,
67,
72, 73
15
67
73,
95, 96
89
73
10D&F
54-59
73,89, 90
1, 2, 3,
88
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
ACCREDITATION STANDARDS
BC BEST
PRACTICES
Sectio
Page #
n
RECOMMENDATION
NUMBER
33-37
8.1
13
64
99, 100
3
5
6B
9
1D
28-29
30-33
34
44-48
25
18,
23, 29,
31-35,
54-58
9
6
9C
6
9C
6D
9C
6D
7A+B
8C
9D
6D
7A+B
8C
9C+D
6D
9C
33-35
45-46
33-37
45-46
35-36
45-46
35-37
37-39
41-43
46
35-37
37-39
41-42
45-46
35-36
45-46
35,
56
34
54, 57,
36,
54, 57, 58
8.2
8.3
8.4
8.5
8.6
8.7
8.8
8.9
For each detergent, solution and disinfectant, the team follows manufacturers
recommendations for use, contact time, shelf life, storage, appropriate dilution,
testing for appropriate concentration and effectiveness, and required PPE.
Following cleaning, and prior to additional reprocessing, the team inspects each
device for cleanliness, functionality, and defects such as breaks, chips, or cracks,
40-45
48
40-45
48, 50
N/A
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
ACCREDITATION STANDARDS
BC BEST
PRACTICES
Sectio
Page #
n
RECOMMENDATION
NUMBER
The team prepares each device or set of devices for sterilization according to
manufacturers instructions, including drying, lubrication, and disassembly.
6
10
33-37
49-52
36
69, 70, 72,
8.11
The team packages each device or set of devices for sterilization using an
appropriate packaging material and process.
The package or container has an externally visible chemical indicator to
differentiate between processed and unprocessed packages.
The team places an internal chemical indicator in each package or container,
according to the organizations quality control processes, to verify that sterilizer
penetration has occurred.
10A+B
49-53
83
10B
10E
10B
10D+E
11B
3
5
10
10D&E
50
57-58
50
55-58
61-62
28-29
30-32
49-59
57-58
85
10B ii+iii
51-52
75
10B
50-52
N/A
10
10B iv
10D
10B iv+v
50-59
52
54-58
52
89,72
11 & 12A
61-62
93,94
8.12
8.13
9.0
The team operates the sterilization equipment and conducts the sterilization
safely and accurately.
9.1
The team uses its most complex or challenging pack or container to verify that all
devices can be sterilized.
The team follows the SOPs, the sterilizers operating manual, and
manufacturers instructions for devices and equipment when loading the
sterilizer.
An appropriate team member verifies the configuration of the load before
beginning the sterilization.
The team follows manufacturers instructions while operating the sterilizer.
Following the sterilization cycle and before unloading, the appropriate team
member verifies that the required parameters have been met.
9.2
9.3
9.4
9.5
9.6
9.7
During unloading, the team inspects all packs, including the results of external
chemical indicators.
The team repeats reprocessing for any items with a damaged pack or seal, or
those that are compressed, torn, wet, or have been dropped on the floor.
85
15, 16, 29
72,
85, 90
74
N/A
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
ACCREDITATION STANDARDS
10.0
10.1
The reprocessing unit or area has an appropriate area for the storage of
sterilized medical devices.
The organization limits and monitors access to the storage area to appropriate
team members.
When cleaning the sterile storage area, staff members minimize the amount of air
turbulence and excess moisture.
10.2
10.3
10.4
10.5
10.6
11.0
11.1
11.2
The sterilized packages are clearly identifiable and distinguished from nonsterilized
items.
11.3
The team is able to track all sterilized items in storage or transported to client care
areas, units, or other organizations.
11.4
BC BEST
PRACTICES
Sectio
Page #
n
RECOMMENDATION
NUMBER
9F
11
9F
11A
11A
47
61-62
47
61
61
64
93
2B
2D
11A
11A&B
11A&B
27
28
61
61-62
61-62
N/A
1C
8
11A
12
1C
10B vii
11
12
6B
10Bv
12A
1C
12A
25
43
61
62-64
24
53
61-62
62-64
34-35
52
62
24-25
62
7, 32, 33,
1C&D
25
8, 9
93
93
92-94
93
93
95-98
15
93,94
33,
95
9
98
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
ACCREDITATION STANDARDS
11.5
The team follows accepted standards of practice to identify when there may be a
problem with sterilization and when a recall may be necessary.
11.6
The team follows an established procedure to recall sterilized items that may have
been compromised.
11.7
11.8
For each recall, the team issues a written, complete notification to all areas of the
organization that use reprocessed medical devices that identifies the items to be
recalled and the actions needed to recall the items.
The team issues a complete and written report of all recalls.
11.9
The team follows a policy to retain recall orders and reports in its files.
12.0
The team has an integrated approach to quality and risk management for its
reprocessing and sterilization services.
12.1
The team has a documented quality management system for its reprocessing and
sterilization services that integrates principles of quality assurance, risk
management, and continual improvement.
As part of the quality management system, the reprocessing team engages in an
annual review of reprocessing and sterilization activities, with formal reports
provided to the organizations senior management.
The quality management system documents are accessible to staff and team
members.
12.2
12.3
12.4
As part of its quality management system, the team trains staff to identify,
assess, prioritize, reduce, and communicate risks in the reprocessing unit or area.
12.5
The team monitors compliance with policies and procedures, safe work
practices, and OHS requirements in the reprocessing unit or area.
12.6
The team verifies and documents the quality of reprocessing services provided in
other areas, or by contracted services or subsidiaries.
BC BEST
PRACTICES
Sectio
Page #
n
RECOMMENDATION
NUMBER
3
12
3
12C&D
3
12C&D
28, 29
62-64
28, 29
63-64
28, 29
63-64
17
97, 98
17
97, 98
17
97, 98
3
12C&D
3
12C&D
3
12
12A
12C
28, 29
63-64
28-29
63-64
28-29
62-64
62
63
17
97, 98
17
97, 98
15, 16, 17
GP
20
86
4
12A&B
4
12C
29, 30
62, 63
29-30
63
N/A
P
3
5
GP
18
28-29
30-32
20-21
23-29
15, 16
N/A
18
98
N/A
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
ACCREDITATION STANDARDS
12.7
12.8
12.9
12.10
The team identifies, investigates, evaluates, and takes appropriate corrective action
for deviations from normal operating procedures or safe work practices, including
critical incidents/accidents and adverse events.
Team leaders review the quality management system regularly.
The team participates in periodic audits.
The team identifies areas for improvement and makes appropriate changes or
improvements.
BC BEST
PRACTICES
Sectio
Page #
n
12A+B
3
12C+D
62-63
28-29
63-64
P
12A
GP
P
12
17
62
20-21
14-19
62-64
RECOMMENDATION
NUMBER
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
1.
BC Ministry of Health
Best Practice Guidelines for the Cleaning, Disinfection and Sterilization of Medical Devices in
Health Authorities
http://www.health.gov.bc.ca/library/publications/year/2011/Best-practice-guidelines-cleaning.doc
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
http://www.collectionscanada.gc.ca/webarchives/20071212094643/www.phacaspc.gc.ca/publicat/ccdr-rmtc/97vol23/23s8/index.html
U.S. Centers for Disease Control and Prevention (CDC)
Guidelines for Disinfection and Sterilization in Health Care Facilities (2008).
http://www.cdc.gov/ncidod/dhqp/index.html
PubMed
PubMed is the National Library of Medicine's search service that provides access to over 15
million citations in biomedical and life sciences journals.
http://www.pubmed.com
Society of Gastroenterology Nurses and Associates (SGNA)
The Society of Gastroenterology Nurses and Associates (SGNA) is a professional organization of
nurses and associates dedicated to the safe and effective practice of gastroenterology and
endoscopy nursing through education, research, advocacy, and collaboration.
www.sgna.org
Association for the Advancement of Medical Instrumentation (AAMI)
The Association for the Advancement of Medical Instrumentation (AAMI) is a non-profit whose
mission is to increase the understanding and beneficial use of medical instrumentation through
effective standards and educational programs, and publications.
www.aami.org
Professional Associations
IAHSCMM International Association of Healthcare Central Service Materiel Management
IAHCSMM offers professional certification programs that are recognized throughout the
healthcare industry and are available to members of the Association and healthcare facilities.
http://www.iahcsmm.org/
ORNAC Operating Room Nurses Association of Canada
ORNAC is an Associate member of the Canadian Nursing Association that aims to enhance and
advance the practice of perioperative Registered Nurses.
http://www.ornac.ca/
| Page 121 of 136 pages
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
PICNet: Provincial Infection Control Network of BC [Internet]. Vancouver (BC): Provincial Infection
Control Network of BC; c20072011 [cited 2011 June 20]. Available from: http://www.picnetbc.ca/
3.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
Endnotes
1
Canadian Standards Association. CAN/CSA-Z314.3-09 Effective Sterilization in Health Care Facilities by the Steam Process.
Rexdale, Ont.: Canadian Standards Association; 2009.
2
Canadian Standards Association. CAN/CSA-Z314.3-09 Effective Sterilization in Health Care Facilities by the Steam Process.
Rexdale, Ont.: Canadian Standards Association; 2009.
3
Canadian Standards Association. CAN/CSA-Z314.3-09 Effective Sterilization in Health Care Facilities by the Steam Process.
Rexdale, Ont.: Canadian Standards Association; 2009.
4
Canadian Standards Association. CAN/CSA Z317.13-07 Infection Control during Construction, Renovation and Maintenance of
Health Care Facilities. Mississauga, Ont.: Canadian Standards Association; 2007.
5
Canadian Standards Association. CAN/CSA-Z314.22-10 Management of loaned, reusable medical devices. Rexdale, Ont.:
Canadian Standards Association; 2010.
6
Canadian Standards Association. CAN/CSA-Z314.3-09 Effective Sterilization in Health Care Facilities by the Steam Process.
Rexdale, Ont.: Canadian Standards Association; 2009.
7
Canadian Standards Association. CAN/CSA-Z314.3-09 Effective Sterilization in Health Care Facilities by the Steam Process.
Rexdale, Ont.: Canadian Standards Association; 2009.
8
Canadian Standards Association. CAN/CSA-Z314.3-09 Effective Sterilization in Health Care Facilities by the Steam Process.
Rexdale, Ont.: Canadian Standards Association; 2009.
9
Canadian Standards Association. CAN/CSA-Z314.3-09 Effective Sterilization in Health Care Facilities by the Steam Process.
Rexdale, Ont.: Canadian Standards Association; 2009.
10
Canadian Standards Association. CAN/CSA-Z314.3-09 Effective Sterilization in Health Care Facilities by the Steam Process.
Rexdale, Ont.: Canadian Standards Association; 2009.
11
Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST58: 2005 Chemical sterilization and high level
disinfection in health care facilities. Arlington, VA: Association for the Advancement of Medical Instrumentation; 2005.
12
BC. Ministry of Health. Best Practices for Infection Prevention and Control Programs in Health Authorities 2007. Available from:
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13
Health Canada. Infection Control Guidelines: Routine practices and additional precautions for preventing the transmission of
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14
BC Centre for Disease Control (BCCDC). Hand Hygiene Fact Sheet [cited September 21, 2010]; Available from:
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17
BC. Ministry of Healthy Living and Sport. Public Health Act, RSBC 2008; [cited September 21, 2010]; Available from:
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18
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http://www.health.gov.bc.ca/library/publications/year/2007/BPGuidelines_Cleaning_Disinfection_Sterilization_MedicalDevices.pdf.
19
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
20
23
BC. Ministry of Health. Home and Community Care Policy Manual, Available from; http://www.health.gov.bc.ca/hcc/policy.html.
27
BC. Ministry of Health. Home and Community Care Policy Manual, Available from; http://www.health.gov.bc.ca/hcc/policy.html.
28
BC. Ministry of Healthy Living and Sport. Public Health Act, RSBC 2008; [cited September 21, 2010]; Available from:
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29
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BC. WorkSafeBC. Workers Compensation Act, RSBC 1996, and Occupational Health and Safety Regulations; Available from:
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33
Canadian Standards Association. CAN/CSA-Z314.3-09 Effective Sterilization in Health Care Facilities by the Steam Process.
Rexdale, Ont.: Canadian Standards Association; 2009.
34
Canadian Standards Association. CAN/CSA Z314.8-08 Decontamination of Reusable Medical Devices. Mississauga, Ont.: Canadian
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35
Canadian Standards Association. CAN/CSA-Z314.3-09 Effective Sterilization in Health Care Facilities by the Steam Process.
Rexdale, Ont.: Canadian Standards Association; 2009.
36
Canadian Standards Association. CAN/CSA Z314.8-08 Decontamination of Reusable Medical Devices. Mississauga, Ont.: Canadian
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37
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38
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39
Canadian Standards Association. CAN/CSA-Z314.3-09 Effective Sterilization in Health Care Facilities by the Steam Process.
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40
Canadian Standards Association. CAN/CSA Z314.8-08 Decontamination of Reusable Medical Devices. Mississauga, Ont.: Canadian
Standards Association; 2008.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
41
Spaulding E. The Role of Chemical Disinfection in the Prevention of Nosocomial Infections. In: International Conference on
Nosocomial Infections; 1970 1971; Chicago, IL: American Hospital Association; 1970. p. 254-74.
42
Canadian Standards Association. CAN/CSA-Z314.3-09 Effective Sterilization in Health Care Facilities by the Steam Process.
Rexdale, Ont.: Canadian Standards Association; 2009.
43
Canadian Standards Association. CAN/CSA Z314.8-08 Decontamination of Reusable Medical Devices. Mississauga, Ont.: Canadian
Standards Association; 2008.
44
Canadian Standards Association. CAN/CSA Z314.8-08 Decontamination of Reusable Medical Devices. Mississauga, Ont.: Canadian
Standards Association; 2008.
45
Canadian Standards Association. CAN/CSA-Z314.22-04 (R2009) Management of Loaned, Shared, and Leased Medical Devices.
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46
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50
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Canadian Standards Association. CAN/CSA-Z314.3-09 Effective Sterilization in Health Care Facilities by the Steam Process.
Rexdale, Ont.: Canadian Standards Association; 2009.
52
Canadian Standards Association. CAN/CSA Z314.8-08 Decontamination of Reusable Medical Devices. Mississauga, Ont.: Canadian
Standards Association; 2008.
53
Canadian Standards Association. CAN/CSA Z314.8-08 Decontamination of Reusable Medical Devices. Mississauga, Ont.: Canadian
Standards Association; 2008.
54
Canadian Standards Association. CAN/CSA Z314.8-08 Decontamination of Reusable Medical Devices. Mississauga, Ont.: Canadian
Standards Association; 2008.
55
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56
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Standards Association; 2008.
57
Association for the advancement of medical instrumentation. AAMI TIR34/Ed.2 and AAMI TIR34:2007 Water for the
Reprocessing of Medical Devices, 2007.
58
Canadian Standards Association. CAN/CSA Z314.8-08 Decontamination of Reusable Medical Devices. Mississauga, Ont.: Canadian
Standards Association; 2008.
59
Canadian Standards Association. CAN/CSA-Z314.3-09 Effective Sterilization in Health Care Facilities by the Steam Process.
Rexdale, Ont.: Canadian Standards Association; 2009.
60
Canadian Standards Association. CAN/CSA Z314.8-08 Decontamination of Reusable Medical Devices. Mississauga, Ont.: Canadian
Standards Association; 2008.
Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities - December 2011
61
Health Canada. Classic Creutzfeldt-Jakob Disease in Canada. An infection control guideline. Can Commun Dis Rep 2002;28 Suppl
5:1-84.
62
Canadian Standards Association. CAN/CSA Z314.8-08 Decontamination of Reusable Medical Devices. Mississauga, Ont.: Canadian
Standards Association; 2008.
63
Canadian Standards Association. CAN/CSA Z314.8-08 Decontamination of Reusable Medical Devices. Mississauga, Ont.: Canadian
Standards Association; 2008.
64
Canadian Standards Association. CAN/CSA-Z314.3-09 Effective Sterilization in Health Care Facilities by the Steam Process.
Rexdale, Ont.: Canadian Standards Association; 2009.
65
Canadian Standards Association. CAN/CSA-Z314.3-09 Effective Sterilization in Health Care Facilities by the Steam Process.
Rexdale, Ont.: Canadian Standards Association; 2009.
66
Canadian Standards Association. CAN/CSA Z314.8-08 Decontamination of Reusable Medical Devices. Mississauga, Ont.: Canadian
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67
Health Canada. Classic Creutzfeldt-Jakob Disease in Canada. An infection control guideline. Can Commun Dis Rep 2002;28 Suppl
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68
Canadian Standards Association. CAN/CSA Z314.8-08 Decontamination of Reusable Medical Devices. Mississauga, Ont.: Canadian
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Canadian Standards Association. CAN/CSA-Z314.3-09 Effective Sterilization in Health Care Facilities by the Steam Process.
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Canadian Standards Association. CAN/CSA Z314.8-08 Decontamination of Reusable Medical Devices. Mississauga, Ont.: Canadian
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Additional Precautions in All Health Care Settings; 2009. [cited August 31, 2009]; Available from:
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Ontario Hospital Association & Ontario Medical Association Joint Committee on Communicable Diseases Surveillance Protocols.
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Rexdale, Ont.: Canadian Standards Association; 2009.
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Ontario. Ontario. Occupational Health and Safety Act, R.S.O. 1990, c.O.1: Control of Exposure to Biological or Chemical Agents,
R.R.O. 1990, Regulation 833 Amended to O. Reg. 607/05. [Part 5: Ceiling Exposure Values (CEV) for Biological and Chemical
Agents]. [cited September 18, 2009]; Available from: http://www.elaws.gov.on.ca/html/source/regs/english/2005/elaws_src_regs_r05607_e.htm.
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Rexdale, Ont.: Canadian Standards Association; 2009.
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Canadian Standards Association. CAN/CSA Z314.8-08 Decontamination of Reusable Medical Devices. Mississauga, Ont.:
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Canadian Standards Association. CAN/CSA-Z314.3-09 Effective Sterilization in Health Care Facilities by the Steam Process.
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Canadian Standards Association. CAN/CSA Z314.8-08 Decontamination of Reusable Medical Devices. Mississauga, Ont.:
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Canadian Standards Association. CAN/CSA-Z314.3-09 Effective Sterilization in Health Care Facilities by the Steam Process.
Rexdale, Ont.: Canadian Standards Association; 2009.
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Canadian Standards Association. CAN/CSA Z314.8-08 Decontamination of Reusable Medical Devices. Mississauga, Ont.: Canadian
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Canadian Standards Association. CAN/CSA-Z314.3-09 Effective Sterilization in Health Care Facilities by the Steam Process.
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Canadian Standards Association. CAN/CSA Z314.8-08 Decontamination of Reusable Medical Devices. Mississauga, Ont.: Canadian
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Canadian Standards Association. CAN/CSA-Z314.3-09 Effective Sterilization in Health Care Facilities by the Steam Process.
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Canadian Standards Association. CAN/CSA-Z314.3-09 Effective Sterilization in Health Care Facilities by the Steam Process.
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Canadian Standards Association. CAN/CSA-Z314.3-09 Effective Sterilization in Health Care Facilities by the Steam Process.
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Canadian Standards Association. CAN/CSA Z314.8-08 Decontamination of Reusable Medical Devices. Mississauga, Ont.:
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Health Canada. Infection Control Guidelines: Hand Washing, Cleaning, Disinfection and Sterilization in Health Care [currently under
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Whyman CA, McDonald SA, Zoutman D. Unsuspected dilution of glutaraldehyde in an automatic washer for flexible fibreoptic
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Canadian Standards Association. CAN/CSA Z314.8-08 Decontamination of Reusable Medical Devices. Mississauga, Ont.:
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Whyman CA, McDonald SA, Zoutman D. Unsuspected dilution of glutaraldehyde in an automatic washer for flexible fibreoptic
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Canadian Standards Association. CAN/CSA Z314.8-08 Decontamination of Reusable Medical Devices. Mississauga, Ont.:
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Whyman CA, McDonald SA, Zoutman D. Unsuspected dilution of glutaraldehyde in an automatic washer for flexible fibreoptic
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